Phoenix Clinical ICON

Primary DI
00857253006040
Brand
Phoenix Clinical ICON
Company
Phoenix Clinical
Model
PJZ
Catalog number
PCI-40-1000-P
Device 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.
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJZCamera, Ophthalmic, General-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857253006040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857253006040008572530060408572530060400857253006040

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
925-462-5000service@phoenix-clinical.com

Regulatory Flags#

DUNS number
949114925
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857253006085Phoenix ICON GO Control BoxPCI 40-10302026-05-14
00857253006019ICON HandpiecePCI 40-10022026-04-03
00857253006033FA ModulePCI 40-10042026-04-03
00857253006071DiffuserPCI 40-10172026-04-03
00857253006101Phoenix ICON with Training KitPCI 40-11002026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPCI 40-1100FA2026-04-03
00857253006132Phoenix ICON GO with Training KitPCI 40-21002026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit PCI 40-2100FA2026-04-03
00857253006057Phoenix ICON Cart SystemPCI 40-10002021-11-30
00857253006088Phoenix ICON GOPCI 40-20012021-02-21
00857253006002Phoenix Clinical ICON CartPCI 40-1001PCI 40-10012016-11-18
00857253006026Phoenix Clinical ICON Control BoxPCI 40-1003PCI 40-10032016-11-18
00857253006064Phoenix Clinical White Light ModulePCI 40-1005PCI 40-10052016-11-18

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