Samsung Medison Co., Ltd. FDA Approvals

0 new drug approvals and 27 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
EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System510(k)Sep 25, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 25, 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;510(k)Jul 28, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 28, 2026
EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System510(k)Mar 27, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 27, 2026
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System510(k)Jan 5, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 5, 2026
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System510(k)Jul 18, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 18, 2025
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System510(k)Feb 12, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 12, 2025
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System510(k)Dec 10, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 10, 2024
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System510(k)Nov 27, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 27, 2024
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System510(k)Oct 11, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 11, 2024
SonoSync510(k)Aug 23, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 23, 2024
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System510(k)Jun 21, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 21, 2024
RS85 Diagnostic Ultrasound System510(k)Jun 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 12, 2024
HM70 EVO Diagnostic Ultrasound System510(k)Dec 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 21, 2023
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System510(k)Oct 3, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 3, 2023
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System510(k)Apr 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 21, 2023
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System510(k)Feb 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 13, 2023
HS40 Diagnostic Ultrasound System510(k)Aug 22, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 22, 2022
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System510(k)Jun 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 29, 2022
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System510(k)Jun 17, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 17, 2022
HM70 EVO Diagnostic Ultrasound System510(k)May 6, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 6, 2022
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System510(k)Apr 5, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 5, 2022
HERA W9, HERA W10 Diagnostic Ultrasound System510(k)Sep 9, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 9, 2021
V8 Diagnostic Ultrasound System510(k)Sep 8, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2021
HM70 EVO Diagnostic Ultrasound System510(k)Jul 9, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 9, 2021
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System510(k)Jun 24, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 24, 2021
HS40 Diagnostic Ultrasound System510(k)May 13, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 13, 2021
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System510(k)Apr 9, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 9, 2021

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