Vue PACS 1201284

GUDID 60889971041692

PACS WFM SW < 25K EXAMS/YR

CARESTREAM HEALTH, INC.

Radiology picture archiving and communication system application software

• Primary Device ID: 60889971041692
• NIH Device Record Key: 37677f2f-2947-4335-adf7-4be8c932b8aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vue PACS
• Version Model Number: Vue PACS
• Catalog Number: 1201284
• 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	60889971041692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110919

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-03
• Device Publish Date: 2016-09-16

On-Brand Devices [Vue PACS]

• 60889971047809: UNLIMITED READING LIC < 25K EX/YR
• 60889971041692: PACS WFM SW < 25K EXAMS/YR