CARESTREAM Image Suite 6701171

GUDID 60889976701171

IMAGESUITE CONSOLE SW

CARESTREAM HEALTH, INC.

Radiology PACS software

• Primary Device ID: 60889976701171
• NIH Device Record Key: 7c0f645c-4cd0-4ef5-b4fa-8aea93c0d893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESTREAM Image Suite
• Version Model Number: CARESTREAM Image Suite
• Catalog Number: 6701171
• 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	60889976701171 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-07
• Device Publish Date: 2022-02-25

On-Brand Devices [CARESTREAM Image Suite]

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