← Back to catalogue

iFusion

FDA UDI

Class II (US FDA UDI)

by Optovue, Inc.

Identity

Trade Name
iFusion FDA UDI
Generic Name
Ophthalmic fundus camera FDA UDI
Device Name
iVue NR for iFusion USCFG 120V FDA UDI
Model / Reference
iFusion FDA UDI
Description
iVue NR for iFusion USCFG 120V FDA UDI

Identifiers

Catalog Number
700-49001-004 FDA UDI
Primary DI / UDI-DI
00858848006186 FDA UDI
510(k) Number
K130656 FDA UDI
FDA Product Code
OBO FDA UDI
HKI FDA UDI
GMDN Term
Ophthalmic fundus camera FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1570 FDA UDI
886.1120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic fundus cameraOphthalmic spectral-domain optical coherence tomography system

iFusion by Optovue, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic spectral-domain optical coherence tomography system.

Cleared under the same submission

K130656 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Optovue, Inc.

Sources (1)

  • FDA UDI 951211e0-aaa6-4467-b1f5-7115ada2c604 36 fields · synced May 30, 2026