Merge iConnect Access

GUDID 00842000100645

Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00842000100645
• NIH Device Record Key: c35c419e-7753-46b1-a4d1-f6f271698d77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge iConnect Access
• Version Model Number: 6.4
• 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	00842000100645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092915

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-17

On-Brand Devices [Merge iConnect Access]

• 00842000100645: Software application that provides internet access to multi-modality softcopy medical images, re
• 00842000100126: Standalone software application.