Vita CR System 1919877

GUDID 60889971919878

IMAGE PROCESSING SOFTWARE / FOR VITA CR

CARESTREAM HEALTH, INC.

Computed radiography digital imaging scanner

• Primary Device ID: 60889971919878
• NIH Device Record Key: eb8b2229-37c1-4217-abc4-f371bc7f8f7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vita CR System
• Version Model Number: Vita CR System
• Catalog Number: 1919877
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889971919878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073670

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-03

On-Brand Devices [Vita CR System]

• 60889978002535: VITA CR FOR IDEXX
• 60889978002528: VITA CR SYSTEM
• 60889971919878: IMAGE PROCESSING SOFTWARE / FOR VITA CR
• 60889971742568: VITA CR SYSTEM- stgd
• 60889971067692: NB VITA CR SOLUTION W / COMPUTER
• 60889971024084: VITA V3.2 LITE SOFTWARE