Prowess
510(k) K032456
Prowess is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K032456 on 16 Oct 2003, active 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 | FDA 510(k)SESE | NumberK032456 | Date16 Oct 2003 | StatusActive |
Official records
- FDA 510(k) database K032456
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K032456
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Panther Brachy version 5.0 | version 5.0 | 00859032007002 | — | No longer on the market |
| Panther TPS v5.6 | v5.6 | 00859032007064 | — | No longer on the market |
| Panther TPS version 5.51 | version 5.51 | 00868603000236 | — | No longer on the market |
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