Theraview C01-01-00
Theraview C01-01-00 is a Class II device made by Cablon Medical B.V., cleared under FDA 510(k) K960510 on 22 Apr 1996 and listed in FDA GUDID since 11 Nov 2024 (UDI-DI 08717953004000), active as of 23 Oct 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 | Number08717953004000 | Date11 Nov 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK960510 | Date22 Apr 1996 | StatusActive |
Official records
- AccessGUDID record 08717953004000
- FDA 510(k) database K960510
Across registries
- FDA 510(k) K960510 decided 22 Apr 1996 Active
- FDA GUDID UDI-DI 08717953004000 listed 11 Nov 2024 Listed
Timeline
- Cleared FDA 510(k) K960510
- Listed FDA GUDID 08717953004000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Theraview
- Generic name
- Radiation therapy software
- Model / Ref / Catalog
- C01-01-00
- Primary DI / UDI-DI
- 08717953004000
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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