FDA.reportPublic FDA data

Phoenix Clinical ICON Cart

Primary DI
00857253006002
Brand
Phoenix Clinical ICON Cart
Company
Phoenix Clinical
Model
PCI 40-1001
Catalog number
PCI 40-1001
Device description
Phoenix Clinical ICON cart assembly.
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00857253006002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857253006002008572530060028572530060020857253006002

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

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
00857253006026Phoenix Clinical ICON Control BoxPCI 40-1003PCI 40-10032016-11-18
00857253006040Phoenix Clinical ICONPJZPCI-40-1000-P2016-11-18
00857253006064Phoenix Clinical White Light ModulePCI 40-1005PCI 40-10052016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010859193OptaseScope Health Inc.PJZ2026-05-01
00860014277559MarcoLombart Brothers, Inc.PJZ2026-03-02
06430046260993Optomed Lumo Camera setOptomed OyPJZ2025-11-13
00860012447121EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447138EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447145EyeCasterInnovations Lightx IncPJZ2025-11-12
06973211070619Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071500Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071517Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
00850067214229identifeye Camera System, tabletIdentifeye Health Inc.PJZ2025-07-07
00850067214236identifeye Camera System, power supplyIdentifeye Health Inc.PJZ2025-07-07
00850067214274identifeye Camera SystemIdentifeye Health Inc.PJZ2025-07-07
00850067214281identifeye Camera System, reconditionedIdentifeye Health Inc.PJZ2025-07-07
06976107790301AirdocChangsha Airdoc Health Technology Co., Ltd.PJZ2024-09-27
07908616100097Eyer 2 BasicPHELCOM TECHNOLOGIES SAPJZ2024-09-23
00860011978305EntireEye PortableRETIVUE, LLCPJZ2024-07-18
00811608014708Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00811608014739Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00860010826812Oivi Opthalmic Fundus CameraOivi ASPJZ2024-01-15
00853501008002Spect Ophthalmic CameraSpect Inc.PJZ2023-08-10
10860000249543Verily Retinal CameraVERILY LIFE SCIENCES LLCPJZ2023-05-24
07908616100042EyerPHELCOM TECHNOLOGIES SAPJZ2023-04-27
08056389701405ME-CHECK 4ESPANSIONE MARKETING SPAPJZ2023-04-05
00811608013770Volk VistaViewVOLK OPTICAL INC.PJZ2022-11-16
00850038195229Eli EzerU.S. OPHTHALMIC, L.L.C.PJZ2022-11-03
06945087500088MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.PJZ2022-11-02
00628678036017WRI-1Cellview Imaging Inc.PJZ2022-09-08
00628678036055WRI-1Cellview Imaging Inc.PJZ2022-09-08
06973211070008Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2022-06-08
08906096520052RemidioREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDPJZ2022-01-31