FDA.reportPublic FDA data

OPTOVUE, INC.

Matched from indexed company URL: Optovue, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059509023005950902OPTOVUE, INC.1N2026-01-01231 Charcot Avenue San Jose CA US 95131

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00858848006285iStand - iStand 2866-941-9240service@optovue.com
00858848006728RTVue XR Avanti - Ophthalmic Optical Coherence Tomography System with 100/240V Table866-941-9240service@optovue.com
00858848006735iScan - Ophthalmic Optical Coherence Tomography System866-941-9240service@optovue.com
00858848006742iScan - Ophthalmic Optical Coherence Tomography System866-941-9240service@optovue.com
00858848006759iVue - Assy Scanner iVue 80866-941-9240service@optovue.com
00858848006766iFusion - iFusion 80 with 12 MP Camera866-941-9240service@optovue.com
00858848006773iVue - iVue 80866-941-9240service@optovue.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
672151139665069K222166SOLIXOBO2022-11-09
672151112714625K180660AvantiOBO2018-06-08
672151174010364K163475iVueOBO2017-06-09
672151604274709K153080RTVue XR OCT Avanti with AngioVue SoftwareHLI2016-02-11
672151876796801K133892IVUE 500HLI2014-03-19
672151339394576K130656IFUSIONHKI2013-07-03
672151214128884K122572ICAM FUNDUS CAMERAHKI2013-01-11
672151055800969K121739IVUE WITH NORMATIVE DATABASEHLI2013-01-18
672151699539731K120238RTVUE XR OCTHLI2012-04-03
672151311022752K111505RTVUE CAM WITH CORNEAL POWER UPGRADEOBO2011-09-08
672151509302858K103266ISTANDHLI2011-06-03
672151386402177K101505RTVUE MODEL RTVUE 100HLI2010-09-15
672151913263448K100861R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100HLI2010-06-17
672151725850720K091404IVUE, MODEL 100OBO2010-04-22
672151057156742K071250CA, MODEL: CAMOBO2007-09-28
672152052562787K062552RTVUEOBO2006-10-06
672151458591513
672151858829040
672152047456427

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBO72022-11-09
HLI72016-02-11
HKI22013-07-03

PMN#

SOLIX

2022-11-09

Optovue, Inc.

IVue

2017-06-09

Optovue, Inc.

RTVUE

2006-10-06

OPTOVUE, INC.

GUDID#

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