FDA Registration
Active
🇺🇸 United States
Varian Medical Systems, Inc
Reg #: 2916710
·
FEI: 2916710
·
Expires 2026
Products
5
Proprietary Names
46
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- Varian Medical Systems, Inc
- Registration Number
- 2916710
- FEI Number
- 2916710
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 911 Hansen Way
- City
- PALO ALTO
- State
- CA
- ZIP
- 94304
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133331
Owner / Operator
- Firm Name
- Varian Medical Systems, Inc
- Operator Number
- 2914292
- Address
- 3100 Hansen Way, --
- City
- Palo Alto
- State
- CA
- Postal Code
- 94304
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2014-03-10 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2017-04-21 |
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 2000-04-26 |
| System, Simulation, Radiation Therapy | KPQ | Class 2 | Radiology | No | 2007-12-07 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2016-02-24 |
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
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
Varian High Energy Linear Accelerator
Halcyon Ethos Radiotherapy System
Trilogy Radiotherapy Delivery System
Varian Verification System
Varian Treatment (VTx)
Calypso System
Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
Mobius3D (4.1)
High-Definition 120 Multileaf Collimator
Integrated Collimator Verification and Interlock System (ICVI)
ICVI
MLC 8
4D Integrated Treatment Console v13 MR4
Halcyon, Ethos Radiotherapy System (5)
Halcyon
Ethos Radiotherapy System
Mobius3D
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility