Merge Cardio

GUDID 00842000100928

Standalone software application

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology 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 Radiological PACS software

• Primary Device ID: 00842000100928
• NIH Device Record Key: a4e892e2-12f2-4785-be96-c3a1fcb8ee6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Cardio
• Version Model Number: 12.1
• 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	00842000100928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051649

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: 2021-09-29
• Device Publish Date: 2021-09-21

On-Brand Devices [Merge Cardio]

• 00842000100591: Standalone software application
• 00842000100416: Standalone software application
• 00842000100041: Standalone software application.
• 00842000100768: 12.0.1
• 00842000100928: Standalone software application
• 00842000101123: Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascu