Panther StereoSeed
510(k) K143514
Panther StereoSeed is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K143514 on 11 Dec 2015, 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 | NumberK143514 | Date11 Dec 2015 | StatusActive |
Official records
- FDA 510(k) database K143514
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- Withdrawn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 K143514
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 |
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