iScan iVue 500
iScan iVue 500 (700-52800-001) is a Class II device made by Optovue, Inc., cleared under FDA 510(k) K133892 on 19 Mar 2014 and listed in FDA GUDID since 31 Oct 2017 (UDI-DI 00858848006421), active as of 22 Oct 2026. 2 FDA recalls are 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 | Number00858848006421 | Date31 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133892 | Date19 Mar 2014 | StatusActive |
Official records
- AccessGUDID record 00858848006421
- FDA 510(k) database K133892
Across registries
- FDA 510(k) K133892 decided 19 Mar 2014 Active
- FDA GUDID UDI-DI 00858848006421 listed 31 Oct 2017 Listed
Recalls
-
- Terminated Z-0010-2018
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
-
- Terminated Z-1498-2016
A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map.
Timeline
- Cleared FDA 510(k) K133892
- Recall initiated FDA recalls Z-1498-2016
- Recall initiated FDA recalls Z-0010-2018
- Listed FDA GUDID 00858848006421
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iScan
- Generic name
- Ophthalmic spectral-domain optical coherence tomography system
- Model / Ref / Catalog
- iVue 500, 700-52800-001
- Primary DI / UDI-DI
- 00858848006421
- 510(k) Number
- FDA product code
- HLI
- GMDN term
- Ophthalmic spectral-domain optical coherence tomography system
- Device class
- Class II
- Regulation number
- 886.1570
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic spectral-domain optical coherence tomography system.