iFusion
iFusion (700-49001-005) 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 21 Jan 2019 (UDI-DI 00858848006636), 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 | Number00858848006636 | Date21 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130656 | Date3 Jul 2013 | StatusActive |
Official records
- AccessGUDID record 00858848006636
- FDA 510(k) database K130656
Across registries
- FDA 510(k) K130656 decided 3 Jul 2013 Active
- FDA GUDID UDI-DI 00858848006636 listed 21 Jan 2019 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
- Recall initiated FDA recalls Z-0009-2018
- Listed FDA GUDID 00858848006636
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Ophthalmic spectral-domain optical coherence tomography system
- Model / Ref / Catalog
- iFusion, 700-49001-005
- Primary DI / UDI-DI
- 00858848006636
- 510(k) Number
- FDA product code
- HKI, OBO
- GMDN term
- Ophthalmic spectral-domain optical coherence tomography system
- Device class
- Class II
- Regulation number
- 886.1120, 886.1570
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic spectral-domain optical coherence tomography system.