FDA.reportPublic FDA data

iFusion

Primary DI
00858848006643
Brand
iFusion
Company
OPTOVUE, INC.
Model
iFusion
Catalog number
700-49002-005
Device description
iVue NR for iFusion 230V
Published
2019-01-21
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
00858848006643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858848006643008588480066438588480066430858848006643

GMDN Terms#

Term, Definition table
TermDefinition
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.

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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