CARESTREAM Image Suite 1055987

GUDID 60889971055989

IMAGE SUITE / V4 SW MEDICAL APP

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: 60889971055989
• NIH Device Record Key: eb474747-e645-43a8-ab3d-2dfe5e698f08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESTREAM Image Suite
• Version Model Number: CARESTREAM Image Suite
• Catalog Number: 1055987
• 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	60889971055989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100094

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: 2019-01-07
• Device Publish Date: 2016-09-16

On-Brand Devices [CARESTREAM Image Suite]

• 60889971055989: IMAGE SUITE / V4 SW MEDICAL APP
• 60889976701171: IMAGESUITE CONSOLE SW