Merge PACS

GUDID 00842000100690

Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage. Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.).

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00842000100690
• NIH Device Record Key: f38fe42b-b666-40be-bfc3-9df6c04e525c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge PACS
• Version Model Number: 7.3
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842000100690 [Primary]

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: 2
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-01-04

On-Brand Devices [Merge PACS]

• 00842000100737: 8.0
• 00842000100690: Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adju
• 00842000100607: Standalone software application
• 00842000100560: Standalone software application
• 00842000100508: Standalone software application
• 00842000100409: 7.2
• 00842000100072: Standalone software application
• 00842000100805: 8.1
• 00842000100478: 7.1.2.1
• 00842000100935: 8.2
• 00842000101086: 9.0
• 00842000101147: 9.1
• 00842000101154: 9.2
• 00842000101208: 9.3
• 00842000101215: 9.4