Identity
- Trade Name
- Phoenix ICON Cart System FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. FDA UDI
- Model / Reference
- PCI 40-1000 FDA UDI
- Description
- The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857253006057 FDA UDI
- 510(k) Number
- K170527 FDA UDI
- FDA Product Code
- HKI FDA UDI
- GMDN Term
- Ophthalmic fundus camera 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic fundus camera
Phoenix ICON Cart System by Phoenix Clinical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RetCam 3 — Natus Medical, Inc. · Class II
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- VISUCAM 224 — Carl Zeiss Meditec AG · Class II
- NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · 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
- Phoenix Clinical
Sources (1)
- FDA UDI a438073a-b7bd-4f0a-b8f0-cbdf619eea16 35 fields · synced Jun 8, 2026