Identity
- Trade Name
- Fundus Photo FDA UDI
- Generic Name
- Ophthalmic image analysis software FDA UDI
- Device Name
- Fundus Photo Digital Imaging System including hardware and/or software FDA UDI
- Model / Reference
- CFD-440 FDA UDI
- Description
- Fundus Photo Digital Imaging System including hardware and/or software FDA UDI
Identifiers
- Catalog Number
- CFD-440 FDA UDI
- Primary DI / UDI-DI
- 00860010658109 FDA UDI
- 510(k) Number
- K093071 FDA UDI
- FDA Product Code
- HKI FDA UDI
- GMDN Term
- Ophthalmic image analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 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
No
FDA UDI
Category: Ophthalmic image analysis softwareMulti-purpose digital medical camera lens, intraocular, visible/infrared light
Fundus Photo by Fundus Photo, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic image analysis software.
- Remidio — Remidio Innovative Solutions Private Limited · Class II
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
- Fundus Photo, LLC
Sources (1)
- FDA UDI 45cc080e-016c-4277-9663-f8b912d879fd 35 fields · synced May 31, 2026