FDA.reportPublic FDA data

iVue

Primary DI
00858848006759
Brand
iVue
Company
OPTOVUE, INC.
Model
iVue 100
Catalog number
700-54520-001
Device description
Assy Scanner iVue 80
Published
2020-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121739000IVUE WITH NORMATIVE DATABASEOptovue, Inc.2013-01-18HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858848006759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858848006759008588480067598588480067590858848006759

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic spectral-domain optical coherence tomography systemA mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.

Contacts#

Phone, Email table
PhoneEmail
866-941-9240service@optovue.com

Regulatory Flags#

DUNS number
196500461
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858848006285iStandiStand700-48491-0012016-08-03
00858848006766iFusioniFusion700-54542-0012020-08-24
00858848006773iVueiVue 100700-54543-0012020-08-24
00858848006780iCamiCam100700-54524-0012020-08-24
00858848006735iScaniVue 500700-52800-0022020-02-13
00858848006742iScaniVue 500700-52801-0022020-02-13
00858848006728RTVue XR Avanti100700-54345-0012020-02-03
00858848006704RTVue XR Avanti100700-51134-0052019-09-20
00858848006667RTVue XR Avanti ScannerAvanti Scanner500-50845-0032019-06-12
00858848006674RTVue XR Avanti100700-51134-0042019-06-12
00858848006001AvantiRTVue XR100-1700-48076-0042016-08-31
00858848006018iScaniVue 500700-49428-0032016-08-31
00858848006025AvantiRTVue XR100-2700-48098-0042016-08-31
00858848006032AvantiRTVue XR Scanner500-47760-0052016-08-31
00858848006049iVueiVue 100-1700-47817-0042016-08-31
00858848006056iVueiVue 100-1700-47818-0042016-08-31
00858848006063iVueiVue 100700-47826-0052016-08-31
00858848006070iVueiVue 100700-47827-0052016-08-31
00858848006087iVueiVue 100700-48355-0052016-08-31
00858848006094iVueiVue 100-2700-48577-0042016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095544135zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544197zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544500zumaxZumax Medical Co., LTDHLI2026-05-20
06942576062461RobotrakRobotrak Technologies Co., LtdHLI2026-04-30
00697077003081Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2025-07-14
04549292147216CANON INC.CANON INC.HLI2025-05-02
00697077003050Amico Diagnostic, Inc.Amico Diagnostic IncorporatedHLI2024-09-18
00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755120307INDIRECT OPHTHALMOSCOPE MONOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755153541OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755153695OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181704OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181711OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
00732094346930Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346947Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346954Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346961Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094347555Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346978Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346985Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346992Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347005Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347012Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347029Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05