ClarifEye - 1
by Philips Medical Systems Nederland B.V.
ClarifEye - 1 (002120) is a Class II device made by Philips Medical Systems Nederland B.V., cleared under FDA 510(k) K201743 on 23 Feb 2021 and listed in FDA GUDID since 12 Mar 2021 (UDI-DI 00884838104570), 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 | GUDID listing | Number00884838104570 | Date12 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201743 | Date23 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 00884838104570
- FDA 510(k) database K201743
Across registries
- FDA 510(k) K201743 decided 23 Feb 2021 Active
- FDA GUDID UDI-DI 00884838104570 listed 12 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K201743
- Listed FDA GUDID 00884838104570
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ClarifEye
- Generic name
- Stereotactic system application software
- Model / Ref / Catalog
- ClarifEye - 1, 002120
- Primary DI / UDI-DI
- 00884838104570
- 510(k) Number
- FDA product code
- OWB, LLZ, JAK, OLO
- GMDN term
- Stereotactic system application software
- Device class
- Class II
- Regulation number
- 892.1650, 892.2050, 892.1750, 882.4560
- GUDID distribution status
- In Commercial Distribution
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