Panther TPS version 5.51
Panther TPS version 5.51 is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K101076 on 27 Jul 2010 (3 earlier submissions) and listed in FDA GUDID since 11 Jan 2017 (UDI-DI 00868603000236), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 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 | Number00868603000236 | Date11 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101076 | Date27 Jul 2010 | StatusActive |
Official records
- AccessGUDID record 00868603000236
- FDA 510(k) database K101076
- FDA 510(k) database K083502
- FDA 510(k) database K032456
- FDA 510(k) database K984196
Across registries
- FDA 510(k) K101076 decided 27 Jul 2010 Active
- FDA GUDID UDI-DI 00868603000236 listed 11 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K984196
- Cleared FDA 510(k) K032456
- Cleared FDA 510(k) K083502
- Cleared FDA 510(k) K101076
- Listed FDA GUDID 00868603000236
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Panther TPS
- Generic name
- Radiation therapy software
- Model / reference
- version 5.51
- Primary DI / UDI-DI
- 00868603000236
- FDA product code
- MUJ
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- Not in Commercial Distribution
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