Panther OIS 3.1
Panther OIS 3.1 is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K211760 on 28 Sep 2021 and listed in FDA GUDID since 19 Dec 2024 (UDI-DI 00859032007224), 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 | GUDID listing | Number00859032007224 | Date19 Dec 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211760 | Date28 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 00859032007224
- FDA 510(k) database K211760
Across registries
- FDA 510(k) K211760 decided 28 Sep 2021 Active
- FDA GUDID UDI-DI 00859032007224 listed 19 Dec 2024 Listed
Timeline
- Cleared FDA 510(k) K211760
- Listed FDA GUDID 00859032007224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Panther OIS
- Generic name
- Radiation therapy treatment record/verify system
- Model / reference
- 3.1
- Primary DI / UDI-DI
- 00859032007224
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiation therapy treatment record/verify system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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