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OPTOVUE, INC.

United States·US-MF-000018369

Last updated September 17, 2026

Information

Country: United States
Address: 231, Charcot Avenue, San Jose, United States
Website: www.visionix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 800 729 1959
PRRC Contact: Peter Sparacio
EUDAMED SRN: US-MF-000018369
FDA FEI Number: 3005950902
DUNS Number: 196500461

Catalogue (86)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
iVue	iVue 100	FDA UDI	Class II	Active
iScan	iVue 500	FDA UDI	Class II	Active
RTVue XR Avanti	100-3	FDA UDI	Class II	Active
iScan	iVue 500	FDA UDI	Class II	Active
RTVue XR Avanti Scanner	Avanti Scanner	FDA UDI	Class II	Active
iFusion	iFusion	FDA UDI	Class II	Active
iVue	iVue 100	FDA UDI	Class II	Active
iScan	iVue 500	FDA UDI	Class II	Active
iVue	iVue 100	FDA UDI	Class II	Active
RTVue XR Avanti Scanner	Avanti Scanner	FDA UDI	Class II	Active
RTVue XR Avanti Scanner	Avanti Scanner	FDA UDI	Class II	Active
iVue	iVue 100-1	FDA UDI	Class II	Active
iFusion	iFusion	FDA UDI	Class II	Active
iVue	iVue 100	FDA UDI	Class II	Active
iFusion	iFusion	FDA UDI	Class II	Active
iScan	iVue 500	FDA UDI	Class II	Active
iVue	iVue 100	FDA UDI	Class II	Active
iCam	iCam100	FDA UDI	Class II	Active
iCam	iCam100	FDA UDI	Class II	Active
iScan	iVue 500	FDA UDI	Class II	Active
Solix	K222166	EUDAMEDFDA 510(k)	Class II	Active
RTVue XR OCT Avanti with AngioVue Software	K153080	FDA 510(k)	Class II	Active
R T Vue With Software 5.0 Model: R I Vue 100	K100861	FDA 510(k)	Class II	Active
Ivue, Model 100	K091404	FDA 510(k)	Class II	Active
Rtvue Model Rtvue 100	K101505	FDA 510(k)	Class II	Active
Rtvue	K062552	FDA 510(k)	Class II	Active
Icam Fundus Camera	K122572	FDA 510(k)	Class II	Active
Ivue 500	K133892	FDA 510(k)	Class II	Active
Ivue With Normative Database	K121739	FDA 510(k)	Class II	Active
Ifusion	K130656	FDA 510(k)	Class II	Active
iVue	K163475	FDA 510(k)	Class II	Active
Ca, Model: Cam	K071250	FDA 510(k)	Class II	Active
Istand	K103266	FDA 510(k)	Class II	Active
Avanti	K180660	FDA 510(k)	Class II	Active
Rtvue Xr Oct	K120238	FDA 510(k)	Class II	Active
Rtvue Cam With Corneal Power Upgrade	K111505	FDA 510(k)	Class II	Active

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 27, 2017	Z-0008-2018	—	terminated	FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Jul 27, 2017	Z-0009-2018	—	terminated	FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Jul 27, 2017	Z-0010-2018	—	terminated	FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Mar 16, 2016	Z-1498-2016	—	terminated	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.
May 14, 2013	Z-1441-2013	—	terminated	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.
Sep 7, 2012	Z-0024-2013	—	terminated	Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.
Feb 21, 2012	Z-1340-2012	—	terminated	A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version.
Jul 20, 2010	Z-1004-2011	—	terminated	Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
Jan 8, 2010	Z-1131-2010	—	terminated	Marketed without proper 510(k)-- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database.