Vue PACS 1201284

GUDID 60889971041692

PACS WFM SW < 25K EXAMS/YR

CARESTREAM HEALTH, INC.

Radiology picture archiving and communication system application software Radiology picture archiving and communication system application software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS 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