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 Number: 3005950902
• FEI Number: 3005950902
• Name: OPTOVUE, INC.
• Owner & Operator: OPTOVUE, INC.
• Contact Address: 2800 Bayview Drive --; Fremont CA 94538 US
• Official Correspondent:
  • Indu P Lakshman
  • x-510-8971575-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2800 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	Device	Date
PMN K222166 Optovue, Inc.	SOLIX	2022-11-09
GUDID 00858848006780 OPTOVUE, INC.	iCam 700-54524-001	2020-09-01
GUDID 00858848006773 OPTOVUE, INC.	iVue 700-54543-001	2020-09-01
GUDID 00858848006766 OPTOVUE, INC.	iFusion 700-54542-001	2020-09-01
GUDID 00858848006742 OPTOVUE, INC.	iScan 700-52801-002	2020-02-21
GUDID 00858848006735 OPTOVUE, INC.	iScan 700-52800-002	2020-02-21
GUDID 00858848006728 OPTOVUE, INC.	RTVue XR Avanti 700-54345-001	2020-02-11
GUDID 00858848006704 OPTOVUE, INC.	RTVue XR Avanti 700-51134-005	2019-09-30
GUDID 00858848006674 OPTOVUE, INC.	RTVue XR Avanti 700-51134-004	2019-06-20
GUDID 00858848006667 OPTOVUE, INC.	RTVue XR Avanti Scanner 500-50845-003	2019-06-20
GUDID 00858848006650 OPTOVUE, INC.	iFusion 700-49003-005	2019-02-21
GUDID 00858848006643 OPTOVUE, INC.	iFusion 700-49002-005	2019-02-21
GUDID 00858848006636 OPTOVUE, INC.	iFusion 700-49001-005	2019-02-21
GUDID 00858848006629 OPTOVUE, INC.	iFusion 700-49000-005	2019-02-21
GUDID 00858848006612 OPTOVUE, INC.	iVue 700-47817-005	2019-02-18
GUDID 00858848006605 OPTOVUE, INC.	iVue 700-47818-005	2019-02-18
GUDID 00858848006568 OPTOVUE, INC.	iVue 700-48577-005	2019-02-18
GUDID 00858848006551 OPTOVUE, INC.	iVue 700-48578-005	2019-02-18
GUDID 00858848006544 OPTOVUE, INC.	iVue 700-48580-005	2019-02-18
GUDID 00858848006537 OPTOVUE, INC.	iVue 700-48581-005	2019-02-18
GUDID 00858848006506 OPTOVUE, INC.	iVue 700-48807-005	2019-02-18
GUDID 00858848006490 OPTOVUE, INC.	iVue 700-48808-005	2019-02-18
GUDID 00858848006483 OPTOVUE, INC.	iVue 700-49007-004	2019-02-18
GUDID 00858848006476 OPTOVUE, INC.	iVue 700-49973-003	2019-02-18
GUDID 00858848006469 OPTOVUE, INC.	RTVue XR Avanti 700-51134-003	2019-01-14
GUDID 00858848006452 OPTOVUE, INC.	RTVue XR Avanti 700-51134-002	2018-10-08
GUDID 00858848006445 OPTOVUE, INC.	Vivicon 700-53597-001	2018-10-08
PMN K180660 | OBO OPTOVUE, INC.	Avanti	2018-08-13
PMN K180660 | HLI OPTOVUE, INC.	Avanti	2018-08-13
PJZ OPTOVUE, INC.	Vivicon Ophthalmic Camera System	2018-08-13
GUDID 00858848006438 OPTOVUE, INC.	iScan 700-52801-001	2018-07-06
GUDID 00858848006421 OPTOVUE, INC.	iScan 700-52800-001	2018-07-06
GUDID 00858848006414 OPTOVUE, INC.	iCam 700-49517-004	2018-07-06
GUDID 00858848006407 OPTOVUE, INC.	iScan 700-49428-004	2018-07-06
GUDID 00858848006391 OPTOVUE, INC.	RTVue XR Avanti 700-48098-005	2018-07-06
GUDID 00858848006384 OPTOVUE, INC.	RTVue XR Avanti 700-48076-005	2018-07-06
GUDID 00858848006377 OPTOVUE, INC.	RTVue XR Avanti Scanner 500-47760-006	2018-07-06
GUDID 00858848006360 OPTOVUE, INC.	RTVue XR Avanti Scanner 500-50845-002	2018-07-06
GUDID 00858848006353 OPTOVUE, INC.	RTVue XR Avanti Scanner 500-50845-001	2018-07-06
GUDID 00858848006346 OPTOVUE, INC.	RTVue XR Avanti 700-51134-001	2018-07-06
GUDID 00858848006339 OPTOVUE, INC.	iCam 700-49517-003	2018-07-06
GUDID 00858848006322 OPTOVUE, INC.	iCam 700-49517-002	2018-07-06
GUDID 00858848006315 OPTOVUE, INC.	iScan 700-49428-002	2018-07-06
GUDID 00858848006308 OPTOVUE, INC.	iFusion 700-48586-003	2018-07-06
GUDID 00858848006292 OPTOVUE, INC.	iFusion 700-48585-003	2018-07-06
GUDID 00858848006285 OPTOVUE, INC.	iStand 700-48491-001	2018-07-06
GUDID 00858848006278 OPTOVUE, INC.	iCam 700-49517-001	2018-07-06
GUDID 00858848006247 OPTOVUE, INC.	iFusion 700-48371-003	2018-07-06
GUDID 00858848006230 OPTOVUE, INC.	iFusion 700-48363-003	2018-07-06
GUDID 00858848006223 OPTOVUE, INC.	iVue 700-49973-002	2018-07-06
GUDID 00858848006216 OPTOVUE, INC.	iVue 700-49007-003	2018-07-06
GUDID 00858848006209 OPTOVUE, INC.	iFusion 700-49003-004	2018-07-06
GUDID 00858848006193 OPTOVUE, INC.	iFusion 700-49002-004	2018-07-06
GUDID 00858848006186 OPTOVUE, INC.	iFusion 700-49001-004	2018-07-06
GUDID 00858848006179 OPTOVUE, INC.	iFusion 700-49000-004	2018-07-06
GUDID 00858848006162 OPTOVUE, INC.	iVue 700-48808-004	2018-07-06
GUDID 00858848006155 OPTOVUE, INC.	iVue 700-48807-004	2018-07-06
GUDID 00858848006148 OPTOVUE, INC.	iVue 700-48806-005	2018-07-06
GUDID 00858848006131 OPTOVUE, INC.	iVue 700-48805-005	2018-07-06
GUDID 00858848006124 OPTOVUE, INC.	iVue 700-48581-004	2018-07-06
GUDID 00858848006117 OPTOVUE, INC.	iVue 700-48580-004	2018-07-06
GUDID 00858848006100 OPTOVUE, INC.	iVue 700-48578-004	2018-07-06
GUDID 00858848006094 OPTOVUE, INC.	iVue 700-48577-004	2018-07-06
GUDID 00858848006087 OPTOVUE, INC.	iVue 700-48355-005	2018-07-06
GUDID 00858848006070 OPTOVUE, INC.	iVue 700-47827-005	2018-07-06
GUDID 00858848006063 OPTOVUE, INC.	iVue 700-47826-005	2018-07-06
GUDID 00858848006056 OPTOVUE, INC.	iVue 700-47818-004	2018-07-06
GUDID 00858848006049 OPTOVUE, INC.	iVue 700-47817-004	2018-07-06
GUDID 00858848006032 OPTOVUE, INC.	Avanti 500-47760-005	2018-07-06
GUDID 00858848006025 OPTOVUE, INC.	Avanti 700-48098-004	2018-07-06
GUDID 00858848006018 OPTOVUE, INC.	iScan 700-49428-003	2018-07-06
GUDID 00858848006001 OPTOVUE, INC.	Avanti 700-48076-004	2018-07-06
PMN K180660 Optovue, Inc.	Avanti	2018-06-08
PMN K163475 | OBO OPTOVUE, INC.	iVue	2017-09-25
PMN K163475 | HLI OPTOVUE, INC.	iVue	2017-09-25
PMN K163475 Optovue, Inc.	IVue	2017-06-09
PMN K153080 | OBO OPTOVUE, INC.	RTVue XR OCT Avanti with AngioVue Software; or; AngioVue Imaging System	2016-03-04
PMN K153080 | HLI OPTOVUE, INC.	RTVue XR OCT Avanti with AngioVue Software; or; AngioVue Imaging System	2016-03-04
PMN K153080 OPTOVUE, INC.	RTVue XR OCT Avanti With AngioVue Software	2016-02-11
PMN K133892 | HLI OPTOVUE, INC.	iVue 500 Powered Ophthalmoscope	2014-04-16
PMN K133892 | HLI OPTOVUE, INC.	iScan	2014-04-16
PMN K133892 OPTOVUE, INC.	IVUE 500	2014-03-19
PMN K130656 | OBO OPTOVUE, INC.	iFusion	2013-10-22
PMN K130656 | HKI OPTOVUE, INC.	iFusion	2013-10-22
PMN K100861 | HLI OPTOVUE, INC.	RTVue 100	2013-10-22
PMN K130656 OPTOVUE, INC.	IFUSION	2013-07-03
PMN K121739 | HLI OPTOVUE, INC.	iVue with NDB	2013-02-22
PMN K121739 | HLI OPTOVUE, INC.	iVue NR	2013-02-22
PMN K071250 | OBO OPTOVUE, INC.	CA (Model: CAM)	2013-02-22
PMN K120238 | HLI OPTOVUE, INC.	RTVue XR	2013-02-21
PMN K120238 | HLI OPTOVUE, INC.	RTVue XR OCT	2013-02-21
PMN K120238 | HLI OPTOVUE, INC.	RTVue XR OCT Avanti	2013-02-21
PMN K120238 | HLI OPTOVUE, INC.	Avanti	2013-02-21
PMN K111505 | OBO OPTOVUE, INC.	RTVue Cam	2013-02-21
PMN K111505 | MMQ OPTOVUE, INC.	RTVue Cam	2013-02-21
PMN K122572 | HKI OPTOVUE, INC.	iCam Fundus Camera	2013-02-20
PMN K122572 | HKI OPTOVUE, INC.	iCam 100	2013-02-20
PMN K122572 | HKI OPTOVUE, INC.	FundusVue	2013-02-20
PMN K121739 OPTOVUE, INC.	IVUE WITH NORMATIVE DATABASE	2013-01-18
PMN K122572 OPTOVUE, INC.	ICAM FUNDUS CAMERA	2013-01-11
PMN K120238 OPTOVUE, INC.	RTVUE XR OCT	2012-04-03
PMN K111505 OPTOVUE, INC.	RTVUE CAM WITH CORNEAL POWER UPGRADE	2011-09-08
PMN K103266 | HLI OPTOVUE, INC.	iStand	2011-07-20
PMN K103266 | HLI OPTOVUE, INC.	Dust Cover Accessory	2011-07-20
PMN K103266 OPTOVUE, INC.	ISTAND	2011-06-03
HRK OPTOVUE, INC.	Table Instrument Manual Ophthalmic	2011-02-24
HRJ OPTOVUE, INC.	Table Instrument Powered Ophthalmic	2011-02-24
PMN K101505 | HLI OPTOVUE, INC.	RTVue Model 100 and 200	2010-12-10
PMN K101505 OPTOVUE, INC.	RTVUE MODEL RTVUE 100	2010-09-15
PMN K100861 OPTOVUE, INC.	R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100	2010-06-17
PMN K091404 | OBO OPTOVUE, INC.	iVue	2010-04-29
PMN K091404 | OBO OPTOVUE, INC.	iVue 100	2010-04-29
PMN K091404 | OBO OPTOVUE, INC.	Dust Cover Accessory	2010-04-29
PMN K091404 OPTOVUE, INC.	IVUE, MODEL 100	2010-04-22
PMN K071250 OPTOVUE, INC.	CA, MODEL: CAM	2007-09-28
PMN K062552 OPTOVUE, INC.	RTVUE	2006-10-06
PMN K062552 | OBO OPTOVUE, INC.	RTVUE	2006-10-06
PMN K062552 | OBO OPTOVUE, INC.	Dust Cover Accessory	2006-10-06

Related Finance Registrations

NCAGE Code	4UET7	OPTOVUE, INC.
CAGE Code	4UET7	OPTOVUE, INC.
S.A.M. Registration	4UET7 [196500461]	OPTOVUE, INC.
SEC	0001332858	Optovue Inc

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091179041	Taipei,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN 2.0 (OEM) WB PARTS OF OPTOV CE TOMOGRAPHY SYSTEM HS CODE 9018.50 3923.90 . .	33 CTN
2020091183739	Taipei,China (Taiwan) -> Oakland, California	IVUE 80KHZ COMPLETE SYSTEM	116 PKG
2020091183739	Taipei,China (Taiwan) -> Oakland, California	IVUE 80KHZ COMPLETE SYSTEM	116 PKG
2020091183739	Taipei,China (Taiwan) -> Oakland, California	IVUE 80KHZ COMPLETE SYSTEM ICAM CAMERA HEAD 1 RIAL 40 EA 47 PLTS 116 PKGS HS CODE 9018.50	116 PKG
2020090933941	Kaohsiung,China (Taiwan) -> Oakland, California	ASSY SCANNER IVUE NR	455 PKG
2020090933941	Kaohsiung,China (Taiwan) -> Oakland, California	ASSY SCANNER IVUE NR	455 PKG
2020090933942	Kaohsiung,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN2.0 (OEM) WB	6 CTN
2020080344894	Shilong,China (Taiwan) -> Oakland, California	ASSY SCANNER IVUE NR	283 PKG
2020080344894	Shilong,China (Taiwan) -> Oakland, California	ASSY SCANNER IVUE NR	283 PKG
2020070731908	Shilong,China (Taiwan) -> Oakland, California	ASSY SCANNER IVUE NR	693 PKG
2020061628646	Taipei,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN2.0 (OEM) WB	8 CTN
2020061561988	Taipei,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN2.0 (OEM) WB	8 CTN