Phoenix ICON Cart System

GUDID 00857253006057

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.

Phoenix Clinical

Ophthalmic fundus camera

• Primary Device ID: 00857253006057
• NIH Device Record Key: a438073a-b7bd-4f0a-b8f0-cbdf619eea16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phoenix ICON Cart System
• Version Model Number: PCI 40-1000
• Company DUNS: 949114925
• Company Name: Phoenix Clinical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com
• Phone: 925-485-1100
• Email: info@phoenixtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857253006057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170527

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-08
• Device Publish Date: 2021-11-30

Devices Manufactured by Phoenix Clinical

• 00857253006057 - Phoenix ICON Cart System: 2021-12-08The 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.
• 00857253006057 - Phoenix ICON Cart System: 2021-12-08 The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is inte
• 00857253006088 - Phoenix ICON GO: 2021-03-01 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 Cart: 2018-03-29 Phoenix Clinical ICON cart assembly.
• 00857253006026 - Phoenix Clinical ICON Control Box: 2018-03-29 Phoenix Clinical ICON Control Box
• 00857253006040 - Phoenix Clinical ICON: 2018-03-29 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 Module: 2018-03-29 White light module for the Phoenix Clinical ICON retinal imaging system.