Panther OIS
510(k) K211760
Panther OIS is a Class II device made by Prowess, Inc., cleared under FDA 510(k) K211760 on 28 Sep 2021, 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 | NumberK211760 | Date28 Sep 2021 | StatusActive |
Official records
- FDA 510(k) database K211760
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K211760
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 OIS 3.1 | 3.1 | 00859032007224 | On the market | |
| Panther OIS 3.11 | 3.11 | 00859032007248 | On the market | |
| Panther OIS 3.12 | 3.12 | 00859032007262 | On the market | |
| Panther OIS 3.2 | 3.2 | 00859032007309 | On the market | |
| Panther OIS 3.3 | 3.3 | 00859032007330 | On the market | |
| Panther OIS 3.31 | 3.31 | 00859032007354 | On the market | |
| Panther OIS 3.4 | 3.4 | 00859032007361 | On the market | |
| Panther OIS 3.5 | 3.5 | 00859032007385 | On the market | |
| Panther OIS v3.0 | v3.0 | 00859032007156 | On the market | |
| Panther OIS|R&V 2.2 | 2.2 | 00859032007033 | No longer on the market |
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