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iVue iVue 100

by Optovue, Inc. 16 variants

iVue iVue 100 (700-48355-005) is a Class II device made by Optovue, Inc., cleared under FDA 510(k) K121739 on 18 Jan 2013, registered in EUDAMED and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00858848006087), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121739

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00858848006087 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121739 Date18 Jan 2013DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K121739 decided 18 Jan 2013 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 00858848006087 listed 31 Aug 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0008-2018 FDA Class II initiated 27 Jul 2017

    FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

    • Terminated Z-1498-2016 FDA Class II initiated 16 Mar 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.

    • Terminated Z-1441-2013 FDA Class III initiated 14 May 2013

    Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.

Timeline

5 dated events

  1. Cleared FDA 510(k) K121739
  2. Recall initiated FDA recalls Z-1441-2013
  3. Recall initiated FDA recalls Z-1498-2016
  4. Listed FDA GUDID 00858848006087
  5. Recall initiated FDA recalls Z-0008-2018

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
iVue
Generic name
Ophthalmic spectral-domain optical coherence tomography system
Model / Ref / Catalog
iVue 100, 700-48355-005
Primary DI / UDI-DI
00858848006087
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

Related devices

Category: Ophthalmic spectral-domain optical coherence tomography system

Cleared under the same submission (K121739)

and 8 more cleared under K121739

Similar devices in this category

Other devices filed under Ophthalmic spectral-domain optical coherence tomography system.

Other devices from Optovue, Inc.

See all devices from Optovue, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)