Siemens Medical Solutions USA, Inc. FDA Approvals

0 new drug approvals and 127 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
syngo.CT Brain Quantification510(k)Sep 25, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 25, 2026
ACUNAV Luxera 4D ICE Catheter510(k)Sep 10, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 10, 2026
MULTIX Impact; MULTIX Impact C510(k)Aug 31, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 31, 2026
syngo.CT Coronary Cockpit510(k)Jun 25, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 25, 2026
MAMMOMAT B.brilliant (11372950)510(k)Jun 18, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 18, 2026
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System510(k)Jun 16, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 16, 2026
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family510(k)May 21, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 21, 2026
syngo Application Software510(k)Apr 29, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 29, 2026
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno510(k)Apr 24, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 24, 2026
ARTIS genio floor; ARTIS icono.explore floor510(k)Apr 23, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 23, 2026
SOMATOM X.cite; SOMATOM X.ceed510(k)Mar 20, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 20, 2026
MI View&GO510(k)Feb 10, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Feb 10, 2026
ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System510(k)Nov 17, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 17, 2025
ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System510(k)Nov 13, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 13, 2025
Cios Select510(k)Nov 4, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 4, 2025
syngo.CT Dual Energy510(k)Oct 15, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 15, 2025
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System510(k)Aug 20, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 20, 2025
Biograph Trinion510(k)Jul 31, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 31, 2025
Cios Spin510(k)Jul 29, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2025
NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime510(k)Jul 28, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 28, 2025
Cios Alpha; Cios Flow510(k)Jul 9, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 9, 2025
syngo.via MI Workflows; Scenium; syngo MBF510(k)Jul 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 3, 2025
SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse510(k)Jul 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 3, 2025
Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems510(k)Jul 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 3, 2025
syngo.CT LVO Detection510(k)Apr 10, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 10, 2025
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime510(k)Feb 12, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 12, 2025
syngo.CT Dual Energy510(k)Jan 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 3, 2025
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System510(k)Nov 19, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 19, 2024
ACUSON Redwood Diagnostic Ultrasound System510(k)Nov 15, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 15, 2024
Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family510(k)Oct 30, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 30, 2024
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)510(k)Oct 22, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 22, 2024
syngo Application Software510(k)Oct 11, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 11, 2024
SOMATOM On.site510(k)Sep 3, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 3, 2024
syngo.via MI Workflows; Scenium; syngo MBF510(k)Aug 30, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 30, 2024
MI View&GO510(k)Aug 30, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 30, 2024
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System510(k)Jul 22, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 22, 2024
ACUSON SC2000 Diagnostic Ultrasound System510(k)Jun 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 12, 2024
ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System510(k)Jun 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 12, 2024
syngo.via RT Image Suite510(k)Apr 26, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 26, 2024
MAGNETOM Viato.Mobile510(k)Mar 29, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 29, 2024
NAEOTOM Alpha510(k)Mar 28, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2024
MAMMOMAT B.brilliant510(k)Mar 27, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 27, 2024
SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed510(k)Mar 26, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 26, 2024
syngo.CT Brain Hemorrhage510(k)Mar 22, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
MAGNETOM Terra; MAGNETOM Terra.X510(k)Mar 22, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
CIARTIC Move (VB10)510(k)Mar 15, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 15, 2024
MAGNETOM Cima.X Fit510(k)Feb 29, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 29, 2024
Biograph VK10510(k)Jan 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 12, 2024
syngo.CT Applications510(k)Jan 4, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 4, 2024
MAGNETOM Sola; MAGNETOM Altea510(k)Dec 22, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2023
syngo Application Software510(k)Dec 20, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 20, 2023
MAGNETOM Cima.X510(k)Dec 18, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 18, 2023
ARTIS pheno (VE30A)510(k)Dec 15, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 15, 2023
ARTIS icono (VE30A)510(k)Dec 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 14, 2023
SOMATOM Pro.Pulse510(k)Dec 6, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 6, 2023
syngo.CT Dual Energy510(k)Nov 30, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 30, 2023
syngo.via MI Workflows; Scenium; syngo MBF510(k)Nov 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 28, 2023
MAGNETOM Avanto fit; MAGNETOM Skyra fit510(k)Nov 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 14, 2023
MAGNETOM Free.Max; MAGNETOM Free.Star510(k)Nov 9, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 9, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System510(k)Oct 30, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 30, 2023
AcuNav Crystal Ultrasound Catheter510(k)Oct 28, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 28, 2023
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit510(k)Oct 23, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 23, 2023
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System510(k)Sep 26, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 26, 2023
Sensis Vibe (VD15)510(k)Sep 15, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 15, 2023
MAGNETOM Viato.Mobile510(k)Sep 6, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 6, 2023
Biograph Vision.X and Biograph Vision.X Edge510(k)Jul 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 13, 2023
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash510(k)Jun 16, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 16, 2023
Symbia Pro.specta VA20A Family510(k)May 17, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 17, 2023
MAGNETOM Amira; MAGNETOM Sempra510(k)Mar 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2023
MAGNETOM Vida510(k)Feb 24, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 24, 2023
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System510(k)Feb 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 13, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System510(k)Feb 6, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Feb 6, 2023
MAMMOVISTA B.smart (VB70)510(k)Jan 12, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jan 12, 2023
Biograph Vision Quadra PET/CT System510(k)Dec 22, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Dec 22, 2022
Cios Select (VA21) Flat Panel510(k)Dec 7, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Dec 7, 2022
Cios Select (VA21) Image Intensifier510(k)Dec 6, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Dec 6, 2022
Syngo Dynamics (Version VA40F)510(k)Nov 14, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 14, 2022
AI-Rad Companion (Musculoskeletal)510(k)Oct 20, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 20, 2022
AI-Rad Companion Organs RT510(k)Oct 14, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 14, 2022
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit510(k)Sep 13, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2022
syngo.via RT Image Suite510(k)Sep 7, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 7, 2022
MI View&GO510(k)Aug 19, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 19, 2022
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System510(k)Aug 16, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 16, 2022
ARTIS icono (Ceiling Configuration)510(k)Jul 19, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 19, 2022
syngo.CT Extended Functionality510(k)Jul 13, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 13, 2022
NAEOTOM Alpha, Scan&GO Software510(k)Jul 12, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 12, 2022
ARTIS icono (VE21) System510(k)Jun 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 29, 2022
ARTIS pheno (VE21) System510(k)Jun 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 29, 2022
MAGNETOM Free.Max, MAGNETOM Free.Star510(k)Jun 24, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 24, 2022
ACUSON Sequoia Diagnostic Ultrasound System510(k)Jun 14, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2022
syngo Dynamics (Version VA40E)510(k)May 20, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 20, 2022
syngo.CT CaScoring510(k)May 17, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 17, 2022
MULTIX Impact E510(k)May 17, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 17, 2022
MAGNETOM Skyra Fit510(k)May 13, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 13, 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A510(k)Apr 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 29, 2022
MAGNETOM Avanto Fit510(k)Apr 1, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 1, 2022
Syngo.CT Dual Energy510(k)Mar 28, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2022
MAGNETOM Vida, MAGNETOM Sola510(k)Mar 11, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 11, 2022
syngo.CT Applications510(k)Mar 7, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 7, 2022
MAGNETOM Vida with syngo MR XA50A510(k)Feb 25, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 25, 2022
ACUSON P500 Ultrasound System510(k)Feb 11, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 11, 2022
syngo.CT Brain Hemorrhage510(k)Jan 28, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 28, 2022
syngo.CT Extended Functionality510(k)Jan 20, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jan 20, 2022
MULTIX Impact, MULTIX Impact C510(k)Dec 13, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Dec 13, 2021
Al-Rad Companion (Pulmonary)510(k)Dec 6, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 6, 2021
MAMMOVISTA B.smart510(k)Nov 12, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 12, 2021
Acuson SC2000 Diagnostic Ultrasound System510(k)Nov 5, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 5, 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter510(k)Oct 15, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 15, 2021
NAEOTOM Alpha, Scan&GO510(k)Sep 30, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 30, 2021
Symbia VA10A Family510(k)Sep 16, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 16, 2021
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software510(k)Aug 27, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 27, 2021
syngo.via RT Image Suite510(k)Jul 30, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 30, 2021
syngo.CT Skull Unfolding510(k)Jul 22, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 22, 2021
ACUSON Sequoia Diagnostic Ultrasound System510(k)Jul 20, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2021
MAGNETOM Free.Max510(k)Jul 1, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2021
syngo.via MI WorkFlows, Scenium, syngo MBF510(k)Jun 10, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 10, 2021
Symbia VA10A Family510(k)May 12, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 12, 2021
syngo. CT Extended Functionalities510(k)Apr 30, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 30, 2021
ACUSON Redwood Diagnostic Ultrasound System510(k)Apr 1, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 1, 2021
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea510(k)Mar 31, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 31, 2021
Cios Select (VA21) Flat Panel510(k)Mar 5, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 5, 2021
Cios Select (VA21) Image Intensifier510(k)Mar 4, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 4, 2021
Biograph Vision Quadra PET/CT System510(k)Mar 3, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 3, 2021
Cios Alpha510(k)Feb 5, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Feb 5, 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter510(k)Jan 19, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jan 19, 2021
MULTIX Impact510(k)Jan 7, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 7, 2021
MULTIX Impact C510(k)Jan 6, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 6, 2021

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