Optovue Inc.
San Jose, CA, US
OPTOVUE, INC. appears in FDA device records in San Jose, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Optovue Inc. between 2006 and 2022. The busiest year on record is 2010, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222166 | SOLIX | OBO | Substantially Equivalent | |
| K180660 | Avanti | OBO | Substantially Equivalent | |
| K163475 | iVue | OBO | Substantially Equivalent | |
| K153080 | RTVue XR OCT Avanti with AngioVue Software | HLI | Substantially Equivalent | |
| K133892 | IVUE 500 | HLI | Substantially Equivalent | |
| K130656 | IFUSION | HKI | Substantially Equivalent | |
| K121739 | IVUE WITH NORMATIVE DATABASE | HLI | Substantially Equivalent | |
| K122572 | ICAM FUNDUS CAMERA | HKI | Substantially Equivalent | |
| K120238 | RTVUE XR OCT | HLI | Substantially Equivalent | |
| K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | OBO | Substantially Equivalent | |
| K103266 | ISTAND | HLI | Substantially Equivalent | |
| K101505 | RTVUE MODEL RTVUE 100 | HLI | Substantially Equivalent | |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | HLI | Substantially Equivalent | |
| K091404 | IVUE, MODEL 100 | OBO | Substantially Equivalent | |
| K071250 | CA, MODEL: CAM | OBO | Substantially Equivalent | |
| K062552 | RTVUE | OBO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005950902 | 3005950902 | OPTOVUE, INC. | 231 Charcot Avenue, San Jose, CA 95131 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0010-2018 | iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Terminated | |
| Z-0009-2018 | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Terminated | |
| Z-0008-2018 | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Terminated | |
| Z-1498-2016 | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber the eye. | 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. | Class II | Terminated | |
| Z-1441-2013 | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. | 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. | Class III | Terminated | |
| Z-0024-2013 | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease. | 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. | Class II | Terminated | |
| Z-1340-2012 | RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) | A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. | Terminated | ||
| Z-1004-2011 | Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM). | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. | Terminated | ||
| Z-1131-2010 | Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain