CADstream

GUDID 00842000100881

Standalone Software Application

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00842000100881
• NIH Device Record Key: 43deb42b-6e9c-4b5b-9fd1-e84b15051881
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CADstream
• Version Model Number: 6.3
• Company DUNS: 065626069
• Company Name: MERGE HEALTHCARE SOLUTIONS 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: true
• 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	00842000100881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092954

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: 2021-02-16
• Device Publish Date: 2021-02-08

On-Brand Devices [CADstream]

• 00842000100638: Standalone Software Application
• 00842000100881: Standalone Software Application
• 00842000101031: Standalone Software Application
• 00842000100003: Standalone Software Application
• 00842000101116: Standalone software application