FDA.reportPublic FDA data

iFusion

Primary DI
00858848006193
Brand
iFusion
Company
OPTOVUE, INC.
Model
iFusion
Catalog number
700-49002-004
Device description
iVue NR for iFusion 230V
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
OBOTomography, Optical CoherenceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130656000IFUSIONOptovue, Inc.2013-07-03HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858848006193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858848006193008588480061938588480061930858848006193

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods#

Method table
Method

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
00858848006759iVueiVue 100700-54520-0012020-08-24
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

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Primary DI, Brand, Company table
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00857253006071DiffuserPhoenix ClinicalHKI2026-04-03
00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
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05713315011924RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011931RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011948RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011962RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
06430046261006Optomed Smartscope FAOptomed OyHKI2025-12-12
06430046260597Smartscope Pro full setOptomed OyHKI2025-11-13
06430046260689Smartscope Pro retinal setOptomed OyHKI2025-11-13
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONHKI2025-09-11
00860014304507OptainOptain Health, Inc.HKI2025-07-07
00860010658109Fundus PhotoFundus PhotoHKI2025-03-31
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKI2025-03-11
00860000249584Verily Numetric Retinal Camera VERILY LIFE SCIENCES LLCHKI2025-02-24
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
00852788008019NeolightNEOLIGHT LLCHKI2025-01-26
00852788008026NeolightNEOLIGHT LLCHKI2025-01-26
00852788008040NeolightNEOLIGHT LLCHKI2025-01-26
00852788008057NeolightNEOLIGHT LLCHKI2025-01-26