CLARUS Review Software
CLARUS Review Software is a Class II device made by Carl Zeiss Meditec, Inc., cleared under FDA 510(k) K181444 on 10 Jan 2019 and listed in FDA GUDID since 25 Sep 2017 (UDI-DI 04057748096051), active as of 23 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 | NumberK181444 | Date10 Jan 2019 | StatusActive |
| United States | GUDID listing | Number04057748096051 | Date25 Sep 2017 | StatusListed |
Official records
- AccessGUDID record 04057748096051
- FDA 510(k) database K181444
Across registries
- FDA 510(k) K181444 decided 10 Jan 2019 Active
- FDA GUDID UDI-DI 04057748096051 listed 25 Sep 2017 Listed
Timeline
- Listed FDA GUDID 04057748096051
- Cleared FDA 510(k) K181444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Clarus
- Generic name
- Ophthalmic fundus camera
- Model / reference
- CLARUS Review Software
- Primary DI / UDI-DI
- 04057748096051
- 510(k) Number
- FDA product code
- QER
- GMDN term
- Ophthalmic fundus camera
- Device class
- Class II
- Regulation number
- 886.1120
- GUDID distribution status
- In Commercial Distribution
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