iFusion
iFusion (700-49002-004) is a Class II device made by Optovue, Inc., cleared under FDA 510(k) K130656 on 3 Jul 2013 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00858848006193), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858848006193 | Date31 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130656 | Date3 Jul 2013 | StatusActive |
Official records
- AccessGUDID record 00858848006193
- FDA 510(k) database K130656
Across registries
- FDA 510(k) K130656 decided 3 Jul 2013 Active
- FDA GUDID UDI-DI 00858848006193 listed 31 Aug 2016 Listed
Recalls
-
- Terminated Z-0009-2018
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Timeline
- Cleared FDA 510(k) K130656
- Listed FDA GUDID 00858848006193
- Recall initiated FDA recalls Z-0009-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Ophthalmic fundus camera
- Model / Ref / Catalog
- iFusion, 700-49002-004
- Primary DI / UDI-DI
- 00858848006193
- 510(k) Number
- FDA product code
- OBO, HKI
- GMDN term
- Ophthalmic fundus camera
- Device class
- Class II
- Regulation number
- 886.1570, 886.1120
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic spectral-domain optical coherence tomography system.