Phoenix Clinical ICON PCI-40-1000-P

GUDID 00857253006040

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.

Phoenix Clinical

Ophthalmic fundus camera
Primary Device ID00857253006040
NIH Device Record Key334c9581-afa7-4de9-97d6-f66df80ac678
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhoenix Clinical ICON
Version Model NumberPJZ
Catalog NumberPCI-40-1000-P
Company DUNS949114925
Company NamePhoenix Clinical
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone925-462-5000
Emailservice@phoenix-clinical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857253006040 [Primary]

FDA Product Code

PJZCamera, Ophthalmic, General-Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-18

Devices Manufactured by Phoenix Clinical

00857253006057 - Phoenix ICON Cart System2021-12-08 The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is inte
00857253006088 - Phoenix ICON GO2021-03-01 The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, co
00857253006002 - Phoenix Clinical ICON Cart2018-03-29 Phoenix Clinical ICON cart assembly.
00857253006026 - Phoenix Clinical ICON Control Box2018-03-29 Phoenix Clinical ICON Control Box
00857253006040 - Phoenix Clinical ICON2018-03-29The 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.
00857253006040 - Phoenix Clinical ICON2018-03-29 The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is capture
00857253006064 - Phoenix Clinical White Light Module2018-03-29 White light module for the Phoenix Clinical ICON retinal imaging system.
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