Identity
- Trade Name
- Phoenix Clinical ICON FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is captured using a hand-held corneal contact camera and is displayed in real-time. The camera contacts the cornea to image the retina and is connected to a cart with the power supplies, controls, computer and display unit. The light source for bright field imaging is a white-light LED located in the hand piece and the hand piece is connected to a mobile through a USB cable and cables for focus motor and LED light. Software in the computer performs library functions and can capture either still or video data. Data can be exported with or without patient information. FDA UDI
- Model / Reference
- PJZ FDA UDI
- Description
- The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is captured using a hand-held corneal contact camera and is displayed in real-time. The camera contacts the cornea to image the retina and is connected to a cart with the power supplies, controls, computer and display unit. The light source for bright field imaging is a white-light LED located in the hand piece and the hand piece is connected to a mobile through a USB cable and cables for focus motor and LED light. Software in the computer performs library functions and can capture either still or video data. Data can be exported with or without patient information. FDA UDI
Identifiers
- Catalog Number
- PCI-40-1000-P FDA UDI
- Primary DI / UDI-DI
- 00857253006040 FDA UDI
- FDA Product Code
- PJZ 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
Yes
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 camera
Phoenix Clinical ICON by Phoenix Clinical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 334c9581-afa7-4de9-97d6-f66df80ac678 35 fields · synced May 30, 2026