Phoenix Clinical

Address:3452 West Thompson Road,Fenton,MI,48430,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Camera, Ophthalmic, General-Use (PJZ) (5) Camera, Ophthalmic, Ac-Powered (HKI) (1)

Premarket Exempt

No Yes

Clear

Phoenix Clinical ICON Cart - 00857253006002 Catalog Number : PCI 40-1001

Device Description : Phoenix Clinical ICON cart assembly.

Device Class : 2

Duns Number: 949114925

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Phoenix Clinical ICON Control Box - 00857253006026 Catalog Number : PCI 40-1003

Device Description : Phoenix Clinical ICON Control Box

Device Class : 2

Duns Number: 949114925

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Phoenix Clinical ICON - 00857253006040 Catalog Number : PCI-40-1000-P

Device Description : The ICON is a wide-field high-resolution retinal imaging system optimized for pe 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.

Device Class : 2

Duns Number: 949114925

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Phoenix ICON Cart System - 00857253006057 Catalog Number :

Device Description : The Phoenix ICON retinal imaging system is a wide-field, handheld, high resoluti 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.

Device Class : 2

Duns Number: 949114925

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Phoenix Clinical White Light Module - 00857253006064 Catalog Number : PCI 40-1005

Device Description : White light module for the Phoenix Clinical ICON retinal imaging system.

Device Class :

Duns Number: 949114925

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Phoenix ICON GO - 00857253006088 Catalog Number :

Device Description : The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, cornea, and external structures of the eye.

Device Class : 2

Duns Number: 949114925

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

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