VariSeed 9.0
by Varian Medical Systems, Inc.
VariSeed 9.0 is a Class II device made by Varian Medical Systems, Inc., cleared under FDA 510(k) K150636 on 8 May 2015 and listed in FDA GUDID since 8 Nov 2016 (UDI-DI 00850800006005), 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 | Number00850800006005 | Date8 Nov 2016 | StatusListed |
| United States | FDA 510(k) | NumberK150636 | Date8 May 2015 | StatusActive |
Official records
- AccessGUDID record 00850800006005
- FDA 510(k) database K150636
Across registries
- FDA 510(k) K150636 decided 8 May 2015 Active
- FDA GUDID UDI-DI 00850800006005 listed 8 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K150636
- Listed FDA GUDID 00850800006005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiation therapy software
- Model / reference
- 9.0
- Primary DI / UDI-DI
- 00850800006005
- 510(k) Number
- FDA product code
- MUJ, KXK
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050, 892.5730
- GUDID distribution status
- In Commercial Distribution
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