Identity
- Trade Name
- iFusion FDA UDI
- Generic Name
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
- Device Name
- iVue NR for iFusion USCFG 230V FDA UDI
- Model / Reference
- iFusion FDA UDI
- Description
- iVue NR for iFusion USCFG 230V FDA UDI
Identifiers
- Catalog Number
- 700-49003-005 FDA UDI
- Primary DI / UDI-DI
- 00858848006650 FDA UDI
- 510(k) Number
- K130656 FDA UDI
- FDA Product Code
- HKI FDA UDIOBO FDA UDI
- GMDN Term
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 FDA UDI886.1570 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
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Optovue, Inc.
Sources (1)
- FDA UDI 32369b89-d275-44df-bf86-f849ec11a0e6 36 fields · synced Jun 6, 2026