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Varian Medical Systems, Inc. FDA Approvals

0 new drug approvals and 48 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
Halcyon, Ethos Radiotherapy System (5.0)510(k)Aug 3, 2026Radiology
Virtual Cone (1.0)510(k)Jul 8, 2026Radiology
Respiratory Gating for Scanners (2.1)510(k)Jun 4, 2026Radiology
ProBeam 360 Proton Therapy System v3.0510(k)Apr 23, 2026Radiology
syngo.via RT Image Suite VC10510(k)Mar 18, 2026Radiology
Halcyon, Ethos Radiotherapy System (5.0)510(k)Jan 21, 2026Radiology
IDENTIFY (5.0)510(k)Dec 16, 2025Radiology
TrueBeam, TrueBeam STX, Edge and VitalBeam510(k)Oct 7, 2025Radiology
CT/ MR Tandem and Ovoid Set510(k)May 9, 2025Radiology
Titanium Flexible Geometry FSD Applicator Set (GM11013400)510(k)Mar 3, 2025Radiology
Identify (4.0)510(k)Feb 7, 2025Radiology
Embozene Color-Advanced Microspheres510(k)Jan 17, 2025Cardiovascular
Mould Probe MR Safe510(k)Jan 10, 2025Radiology
ARIA Radiation Therapy Management System (18.1)510(k)Dec 13, 2024Radiology
Gating Reflector Block510(k)Nov 21, 2024Radiology
Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve510(k)Nov 7, 2024Radiology
ONCOZENE Microspheres510(k)Oct 16, 2024Cardiovascular
Heyman Packing Applicator Set (GM11004580)510(k)Aug 30, 2024Radiology
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)510(k)Jul 19, 2024General, Plastic Surgery
Temperature Sensor Probe (ABL-18TP20)510(k)May 29, 2024General, Plastic Surgery
Flexible Fixation Device for Gynecological Applicators (GM11001960)510(k)May 9, 2024Radiology
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)510(k)Apr 30, 2024Radiology
Universal Endometrial Applicator Set (GM11009840)510(k)Apr 9, 2024Radiology
Kelowna GYN and Crook Prostate Templates510(k)Feb 1, 2024Radiology
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)510(k)Dec 21, 2023Radiology
Halcyon, Ethos Radiotherapy System510(k)Nov 3, 2023Radiology
ProBeam 360° Proton Therapy System v2.0 (Multiroom)510(k)Oct 6, 2023Radiology
TrueBeam, TrueBeam STx, Edge, VitalBeam510(k)Sep 12, 2023Radiology
IDENTIFY510(k)Jul 25, 2023Radiology
Eclipse Treatment Planning System (v18.0)510(k)May 26, 2023Radiology
TrueBeam, TrueBeam STx, Edge, VitalBeam510(k)May 22, 2023Radiology
ARIA Radiation Therapy Management (v18.0)510(k)Apr 10, 2023Radiology
ISOLIS Cryoprobe510(k)Mar 28, 2023General, Plastic Surgery
Aarhus Applicator Set510(k)Mar 13, 2023Radiology
Halcyon, Ethos Radiotherapy System510(k)Jan 17, 2023Radiology
ProBeam 360° Proton Therapy System510(k)Dec 1, 2022Radiology
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device510(k)Sep 14, 2022Radiology
ARIA Radiation Therapy Management (v16.1 MR3)510(k)Jun 17, 2022Radiology
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)510(k)Jun 15, 2022Radiology
TrueBeam, TrueBeam STx, Edge, VitalBeam510(k)Jun 3, 2022Radiology
Respiratory Gating for Scanners v2.0510(k)Jan 14, 2022Radiology
Urethral Warming Catheter Kit510(k)Jan 5, 2022General, Plastic Surgery
AI Segmentation510(k)Sep 2, 2021Radiology
Ethos Treatment Management, Ethos Treatment Planning510(k)Aug 20, 2021Radiology
Identify510(k)Apr 20, 2021Radiology
AI Segmentation510(k)Apr 19, 2021Radiology
4D Integrated Treatment Console510(k)Feb 12, 2021Radiology
Mobius3D510(k)Jan 14, 2021Radiology

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