Varian AI Segmentation 1.0
by Varian Medical Systems, Inc.
Varian AI Segmentation 1.0 is a Class II device made by Varian Medical Systems, Inc., cleared under FDA 510(k) K203469 on 19 Apr 2021 and listed in FDA GUDID since 12 Jun 2021 (UDI-DI 00856100006172), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00856100006172 | Date12 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203469 | Date19 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 00856100006172
- FDA 510(k) database K203469
Across registries
- FDA 510(k) K203469 decided 19 Apr 2021 Active
- FDA GUDID UDI-DI 00856100006172 listed 12 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K203469
- Listed FDA GUDID 00856100006172
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Varian AI Segmentation
- Generic name
- Radiation therapy software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- 00856100006172
- 510(k) Number
- FDA product code
- MUJ
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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