Medical Device Manufacturer · US , Palo Alto , CA

Varian Medical Systems, Inc.

167 submissions · 167 cleared · Since 1997
167
Total
167
Cleared
0
Denied

Varian Medical Systems, Inc. — FDA 510(k) Submissions

Varian Medical Systems, Inc. has submitted 167 FDA 510(k) premarket notifications since 1997, of which 167 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Accelerator, Linear, Medical, System, Applicator, Radionuclide, Remote-controlled, System, Planning, Radiation Therapy Treatment, System, Radiation Therapy, Charged-particle, Medical, System, Simulation, Radiation Therapy . Use the specialty filter in the sidebar to narrow results.

167 devices
1–25 of 167
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · IYE Accelerator, Linear, Medical · Radiology
Jan 2026 126d
IDENTIFY (5.0)
K252919 · IYE Accelerator, Linear, Medical · Radiology
Dec 2025 95d
TrueBeam, TrueBeam STX, Edge and VitalBeam
K252948 · IYE Accelerator, Linear, Medical · Radiology
Oct 2025 21d
CT/ MR Tandem and Ovoid Set
K250299 · JAQ System, Applicator,... · Radiology
May 2025 98d
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · JAQ System, Applicator,... · Radiology
Mar 2025 73d
Identify (4.0)
K242957 · IYE Accelerator, Linear, Medical · Radiology
Feb 2025 135d
Embozene Color-Advanced Microspheres
K242608 · KRD Device, Vascular, For... · Gastroenterology & Urology
Jan 2025 136d
Mould Probe MR Safe
K241764 · JAQ System, Applicator,... · Radiology
Jan 2025 204d
ARIA Radiation Therapy Management System (18.1)
K242463 · MUJ System, Planning,... · Radiology
Dec 2024 116d
Gating Reflector Block
K242874 · JAK System, X-ray,... · Radiology
Nov 2024 59d
Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
K241853 · JAQ System, Applicator,... · Radiology
Nov 2024 133d
ONCOZENE Microspheres
K242794 · KRD Device, Vascular, For... · Cardiovascular
Oct 2024 30d
Heyman Packing Applicator Set (GM11004580)
K241386 · JAQ System, Applicator,... · Radiology
Aug 2024 107d
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)
K240480 · NEY System, Ablation,... · General & Plastic Surgery
Jul 2024 150d
Temperature Sensor Probe (ABL-18TP20)
K240784 · NEY System, Ablation,... · General & Plastic Surgery
May 2024 69d
Flexible Fixation Device for Gynecological Applicators (GM11001960)
K240495 · JAQ System, Applicator,... · Radiology
May 2024 79d
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
K232923 · IYE Accelerator, Linear, Medical · Radiology
Apr 2024 224d
Universal Endometrial Applicator Set (GM11009840)
K232623 · JAQ System, Applicator,... · Radiology
Apr 2024 224d
Kelowna GYN and Crook Prostate Templates
K232949 · JAQ System, Applicator,... · Radiology
Feb 2024 134d
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
K232870 · IYE Accelerator, Linear, Medical · Radiology
Dec 2023 97d
Halcyon, Ethos Radiotherapy System
K232113 · IYE Accelerator, Linear, Medical · Radiology
Nov 2023 112d
ProBeam 360? Proton Therapy System v2.0 (Multiroom)
K231863 · LHN System, Radiation... · Radiology
Oct 2023 105d
TrueBeam, TrueBeam STx, Edge, VitalBeam
K231317 · IYE Accelerator, Linear, Medical · Radiology
Sep 2023 127d
IDENTIFY
K230576 · IYE Accelerator, Linear, Medical · Radiology
Jul 2023 146d
Eclipse Treatment Planning System (v18.0)
K230557 · MUJ System, Planning,... · Radiology
May 2023 87d

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