iCam iCam100
iCam iCam100 (700-49517-002) is a Class II device made by Optovue, Inc., cleared under FDA 510(k) K122572 on 11 Jan 2013 and listed in FDA GUDID since 23 Nov 2016 (UDI-DI 00858848006322), 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 | Number00858848006322 | Date23 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122572 | Date11 Jan 2013 | StatusActive |
Official records
- AccessGUDID record 00858848006322
- FDA 510(k) database K122572
Across registries
- FDA 510(k) K122572 decided 11 Jan 2013 Active
- FDA GUDID UDI-DI 00858848006322 listed 23 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K122572
- Listed FDA GUDID 00858848006322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iCam
- Generic name
- Ophthalmic fundus camera
- Model / Ref / Catalog
- iCam100, 700-49517-002
- Primary DI / UDI-DI
- 00858848006322
- 510(k) Number
- FDA product code
- HKI
- GMDN term
- Ophthalmic fundus camera
- Device class
- Class II
- Regulation number
- 886.1120
- GUDID distribution status
- In Commercial Distribution
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