Optovue Inc

FDA Filings

This page includes the latest FDA filings for Optovue Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005950902
FEI Number3005950902
NameOPTOVUE, INC.
Owner & OperatorOPTOVUE, INC.
Contact Address2800 Bayview Drive --
Fremont CA 94538 US
Official Correspondent
  • Indu P Lakshman
  • x-510-8971575-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2800 Bayview Dr
FREMONT, CA 94538 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Optovue, Inc.
SOLIX2022-11-09
OPTOVUE, INC.
iCam 700-54524-0012020-09-01
OPTOVUE, INC.
iVue 700-54543-0012020-09-01
OPTOVUE, INC.
iFusion 700-54542-0012020-09-01
OPTOVUE, INC.
iScan 700-52801-0022020-02-21
OPTOVUE, INC.
iScan 700-52800-0022020-02-21
OPTOVUE, INC.
RTVue XR Avanti 700-54345-0012020-02-11
OPTOVUE, INC.
RTVue XR Avanti 700-51134-0052019-09-30
OPTOVUE, INC.
RTVue XR Avanti 700-51134-0042019-06-20
OPTOVUE, INC.
RTVue XR Avanti Scanner 500-50845-0032019-06-20
OPTOVUE, INC.
iFusion 700-49003-0052019-02-21
OPTOVUE, INC.
iFusion 700-49002-0052019-02-21
OPTOVUE, INC.
iFusion 700-49001-0052019-02-21
OPTOVUE, INC.
iFusion 700-49000-0052019-02-21
OPTOVUE, INC.
iVue 700-47817-0052019-02-18
OPTOVUE, INC.
iVue 700-47818-0052019-02-18
OPTOVUE, INC.
iVue 700-48577-0052019-02-18
OPTOVUE, INC.
iVue 700-48578-0052019-02-18
OPTOVUE, INC.
iVue 700-48580-0052019-02-18
OPTOVUE, INC.
iVue 700-48581-0052019-02-18
OPTOVUE, INC.
iVue 700-48807-0052019-02-18
OPTOVUE, INC.
iVue 700-48808-0052019-02-18
OPTOVUE, INC.
iVue 700-49007-0042019-02-18
OPTOVUE, INC.
iVue 700-49973-0032019-02-18
OPTOVUE, INC.
RTVue XR Avanti 700-51134-0032019-01-14
OPTOVUE, INC.
RTVue XR Avanti 700-51134-0022018-10-08
OPTOVUE, INC.
Vivicon 700-53597-0012018-10-08
OPTOVUE, INC.
Avanti2018-08-13
OPTOVUE, INC.
Avanti2018-08-13
OPTOVUE, INC.
Vivicon Ophthalmic Camera System2018-08-13
OPTOVUE, INC.
iScan 700-52801-0012018-07-06
OPTOVUE, INC.
iScan 700-52800-0012018-07-06
OPTOVUE, INC.
iCam 700-49517-0042018-07-06
OPTOVUE, INC.
iScan 700-49428-0042018-07-06
OPTOVUE, INC.
RTVue XR Avanti 700-48098-0052018-07-06
OPTOVUE, INC.
RTVue XR Avanti 700-48076-0052018-07-06
OPTOVUE, INC.
RTVue XR Avanti Scanner 500-47760-0062018-07-06
OPTOVUE, INC.
RTVue XR Avanti Scanner 500-50845-0022018-07-06
OPTOVUE, INC.
RTVue XR Avanti Scanner 500-50845-0012018-07-06
OPTOVUE, INC.
RTVue XR Avanti 700-51134-0012018-07-06
OPTOVUE, INC.
iCam 700-49517-0032018-07-06
OPTOVUE, INC.
iCam 700-49517-0022018-07-06
OPTOVUE, INC.
iScan 700-49428-0022018-07-06
OPTOVUE, INC.
iFusion 700-48586-0032018-07-06
OPTOVUE, INC.
iFusion 700-48585-0032018-07-06
OPTOVUE, INC.
iStand 700-48491-0012018-07-06
OPTOVUE, INC.
iCam 700-49517-0012018-07-06
OPTOVUE, INC.
iFusion 700-48371-0032018-07-06
OPTOVUE, INC.
iFusion 700-48363-0032018-07-06
OPTOVUE, INC.
iVue 700-49973-0022018-07-06
OPTOVUE, INC.
iVue 700-49007-0032018-07-06
OPTOVUE, INC.
iFusion 700-49003-0042018-07-06
OPTOVUE, INC.
iFusion 700-49002-0042018-07-06
OPTOVUE, INC.
iFusion 700-49001-0042018-07-06
OPTOVUE, INC.
iFusion 700-49000-0042018-07-06
OPTOVUE, INC.
iVue 700-48808-0042018-07-06
OPTOVUE, INC.
iVue 700-48807-0042018-07-06
OPTOVUE, INC.
iVue 700-48806-0052018-07-06
OPTOVUE, INC.
iVue 700-48805-0052018-07-06
OPTOVUE, INC.
iVue 700-48581-0042018-07-06
OPTOVUE, INC.
iVue 700-48580-0042018-07-06
OPTOVUE, INC.
iVue 700-48578-0042018-07-06
OPTOVUE, INC.
iVue 700-48577-0042018-07-06
OPTOVUE, INC.
iVue 700-48355-0052018-07-06
OPTOVUE, INC.
iVue 700-47827-0052018-07-06
OPTOVUE, INC.
iVue 700-47826-0052018-07-06
OPTOVUE, INC.
iVue 700-47818-0042018-07-06
OPTOVUE, INC.
iVue 700-47817-0042018-07-06
OPTOVUE, INC.
Avanti 500-47760-0052018-07-06
OPTOVUE, INC.
Avanti 700-48098-0042018-07-06
OPTOVUE, INC.
iScan 700-49428-0032018-07-06
OPTOVUE, INC.
Avanti 700-48076-0042018-07-06
Optovue, Inc.
Avanti2018-06-08
OPTOVUE, INC.
iVue2017-09-25
OPTOVUE, INC.
iVue2017-09-25
Optovue, Inc.
IVue2017-06-09
OPTOVUE, INC.
RTVue XR OCT Avanti with AngioVue Software; or; AngioVue Imaging System2016-03-04
OPTOVUE, INC.
RTVue XR OCT Avanti with AngioVue Software; or; AngioVue Imaging System2016-03-04
OPTOVUE, INC.
RTVue XR OCT Avanti With AngioVue Software2016-02-11
OPTOVUE, INC.
iVue 500 Powered Ophthalmoscope2014-04-16
OPTOVUE, INC.
iScan2014-04-16
OPTOVUE, INC.
IVUE 5002014-03-19
OPTOVUE, INC.
iFusion2013-10-22
OPTOVUE, INC.
iFusion2013-10-22
OPTOVUE, INC.
RTVue 1002013-10-22
OPTOVUE, INC.
IFUSION2013-07-03
OPTOVUE, INC.
iVue with NDB2013-02-22
OPTOVUE, INC.
iVue NR2013-02-22
OPTOVUE, INC.
CA (Model: CAM)2013-02-22
OPTOVUE, INC.
RTVue XR2013-02-21
OPTOVUE, INC.
RTVue XR OCT2013-02-21
OPTOVUE, INC.
RTVue XR OCT Avanti2013-02-21
OPTOVUE, INC.
Avanti2013-02-21
OPTOVUE, INC.
RTVue Cam2013-02-21
OPTOVUE, INC.
RTVue Cam2013-02-21
OPTOVUE, INC.
iCam Fundus Camera2013-02-20
OPTOVUE, INC.
iCam 1002013-02-20
OPTOVUE, INC.
FundusVue2013-02-20
OPTOVUE, INC.
IVUE WITH NORMATIVE DATABASE2013-01-18
OPTOVUE, INC.
ICAM FUNDUS CAMERA2013-01-11
OPTOVUE, INC.
RTVUE XR OCT2012-04-03
OPTOVUE, INC.
RTVUE CAM WITH CORNEAL POWER UPGRADE2011-09-08
OPTOVUE, INC.
iStand2011-07-20
OPTOVUE, INC.
Dust Cover Accessory2011-07-20
OPTOVUE, INC.
ISTAND2011-06-03
OPTOVUE, INC.
Table Instrument Manual Ophthalmic2011-02-24
OPTOVUE, INC.
Table Instrument Powered Ophthalmic2011-02-24
OPTOVUE, INC.
RTVue Model 100 and 2002010-12-10
OPTOVUE, INC.
RTVUE MODEL RTVUE 1002010-09-15
OPTOVUE, INC.
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 1002010-06-17
OPTOVUE, INC.
iVue2010-04-29
OPTOVUE, INC.
iVue 1002010-04-29
OPTOVUE, INC.
Dust Cover Accessory2010-04-29
OPTOVUE, INC.
IVUE, MODEL 1002010-04-22
OPTOVUE, INC.
CA, MODEL: CAM2007-09-28
OPTOVUE, INC.
RTVUE2006-10-06
OPTOVUE, INC.
RTVUE2006-10-06
OPTOVUE, INC.
Dust Cover Accessory2006-10-06

Related Finance Registrations
NCAGE Code4UET7OPTOVUE, INC.
CAGE Code4UET7OPTOVUE, INC.
S.A.M. Registration4UET7 [196500461]OPTOVUE, INC.
SEC0001332858Optovue Inc
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091179041Taipei,China (Taiwan) -> Oakland, CaliforniaOCT OPTOVUE ISCAN 2.0 (OEM) WB PARTS OF OPTOV CE TOMOGRAPHY SYSTEM HS CODE 9018.50 3923.90 . .33 CTN
2020091183739Taipei,China (Taiwan) -> Oakland, CaliforniaIVUE 80KHZ COMPLETE SYSTEM116 PKG
2020091183739Taipei,China (Taiwan) -> Oakland, CaliforniaIVUE 80KHZ COMPLETE SYSTEM116 PKG
2020091183739Taipei,China (Taiwan) -> Oakland, CaliforniaIVUE 80KHZ COMPLETE SYSTEM ICAM CAMERA HEAD 1 RIAL 40 EA 47 PLTS 116 PKGS HS CODE 9018.50116 PKG
2020090933941Kaohsiung,China (Taiwan) -> Oakland, CaliforniaASSY SCANNER IVUE NR455 PKG
2020090933941Kaohsiung,China (Taiwan) -> Oakland, CaliforniaASSY SCANNER IVUE NR455 PKG
2020090933942Kaohsiung,China (Taiwan) -> Oakland, CaliforniaOCT OPTOVUE ISCAN2.0 (OEM) WB6 CTN
2020080344894Shilong,China (Taiwan) -> Oakland, CaliforniaASSY SCANNER IVUE NR283 PKG
2020080344894Shilong,China (Taiwan) -> Oakland, CaliforniaASSY SCANNER IVUE NR283 PKG
2020070731908Shilong,China (Taiwan) -> Oakland, CaliforniaASSY SCANNER IVUE NR693 PKG
2020061628646Taipei,China (Taiwan) -> Oakland, CaliforniaOCT OPTOVUE ISCAN2.0 (OEM) WB8 CTN
2020061561988Taipei,China (Taiwan) -> Oakland, CaliforniaOCT OPTOVUE ISCAN2.0 (OEM) WB8 CTN

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