Identity
- Trade Name
- Varian Acuity with Conebeam Computed Tomography FDA UDI
- Generic Name
- Radiation therapy simulation system FDA UDI
- Model / Reference
- 2.1 FDA UDI
Identifiers
- Catalog Number
- TM64001000 FDA UDI
- Primary DI / UDI-DI
- 00856545006010 FDA UDI
- 510(k) Number
- K033339 FDA UDI
- FDA Product Code
- KPQ FDA UDI
- GMDN Term
- Radiation therapy simulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation therapy simulation system
Varian Acuity with Conebeam Computed Tomography by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy simulation system.
- HEAD NECK SIMULATOR — QUALITY ELECTRODYNAMICS LLC · Class II
- MEDIUM TORSO SIMULATOR — QUALITY ELECTRODYNAMICS LLC · Class II
- Acuity iX Radiation Therapy Simulation System — Varian Medical Systems, Inc · Class II
Cleared under the same submission
K033339 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc
Sources (1)
- FDA UDI 2b7fbd19-46ed-412e-8a89-8447a2a3429a 34 fields · synced May 31, 2026