Varian Medical Systems, Inc

FDA Device Registration & Listing · PALO ALTO, CA, US · Registration 2916710

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2916710
FEI Number
2916710
Entity Name
Varian Medical Systems, Inc
City/State/Country
PALO ALTO, CA, US
Establishment Address
911 Hansen Way, PALO ALTO, CA 94304, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Varian Medical Systems, Inc (Owner Number: 2914292)
Owner / Operator Contact Address
3100 Hansen Way, --, Palo Alto, CA 94304, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123137
PMA Number
N/A

All Registered Proprietary Names

4D Treatment Console V.13 EDGE Radiosurgery Suite, EDGE Radiosurgery System, TrueBeam, TrueBeam STx, TrueBeam STx System Halcyon, Ethos Radiotherapy System TrueBeam, TrueBeam STx, Edge TrueBeam, TrueBeam STX, Edge and VitalBeam TrueBeam, TrueBeam STx, Edge, VitalBeam FractionLab DoseLab TG-142 MaximQA Acuity with Conebeam Computed Tomography Varian Head Frame Vitalbeam v2.7 DoseLab Pro Verification Console VitalBeam TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) RPM Respiratory Gating System EDGE Radiosurgery Suite, EDGE Radiosurgery System, TrueBeam, TrueBeam STx, TrueBeam STx System Clinac Cx Trilogy Tx Clinac 2100C Clinac 2100 C/D Clinac 23 EX Clinac 21 EX Clinac iX Clinac 2300 C/D Clinac DHX Trilogy Clinac DMX Novalis Tx Clinac 2100 C/D Clinac 2100C Varian High Energy Linear Accelerator Clinac 21 EX Novalis Tx Clinac DMX Clinac 2300 C/D Clinac DHX Clinac iX Trilogy Clinac Cx Clinac 23 EX Trilogy Tx Halcyon Ethos Radiotherapy System Trilogy Radiotherapy Delivery System Varian Verification System Varian Treatment (VTx) Calypso System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2014-03-10
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2017-04-21
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2024-02-21
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2017-07-20
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-11-18
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2024-01-17
LHO Instrument, Quality-Assurance, Radiologic Radiology Class 1 892.1940 2000-04-26
KPQ System, Simulation, Radiation Therapy Radiology Class 2 892.5840 2007-12-07
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-03-27
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2017-12-11
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2018-03-09
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2016-02-24
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-05-18
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2024-01-17
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2013-03-31
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-03-27
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2014-03-10
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2017-01-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-01-19
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-12-18
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-03-27
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2016-01-12
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2014-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Varian Medical Systems, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007157255 Varian Medical Systems, Inc. Atlanta, GA, US
3007791541 Varian Medical Systems China Co., Ltd. Beijing, CN
3010658895 Varian Medical Systems Particle Therapy GmbH & Co. KG Troisdorf North Rhine-Westphalia, DE
3009754495 Varian Medical Systems International India Private Ltd Pune Maharashtra, IN
3025765259 Varian Medical Systems Haan GmbH Manufacturing site Kemnath Kemnath Bavaria, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K993675 Nomos Corp. PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM 2000-09-05
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12
K013531 Impac Medical Systems, Inc. QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 2001-11-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2012 Elekta, Inc. 2
Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Z-0038-2017 RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden 2
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2916710. Last updated year: 2026. Please use registration number 2916710 when referencing this establishment in official correspondence.
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