iConnect Enterprise Workflow with Merge PACS

GUDID 00842000100133

Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.

MERGE HEALTHCARE SOLUTIONS INC.

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: 00842000100133
• NIH Device Record Key: 68973e5e-15ca-4fff-9d69-f3593828f790
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iConnect Enterprise Workflow with Merge PACS
• Version Model Number: 1.0
• 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	00842000100133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082144

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: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-02-22

Devices Manufactured by MERGE HEALTHCARE SOLUTIONS INC.

• 00842000101123 - Merge Cardio: 2024-02-13 Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management syste
• 00842000101147 - Merge PACS: 2023-12-06
• 00842000101086 - Merge PACS: 2023-09-22
• 00842000101130 - Merge Universal Viewer: 2023-09-07
• 00842000100904 - Merge OrthoTemplates: 2023-06-19 Software implant template
• 00842000101093 - Merge Universal Viewer: 2023-03-27
• 00842000101116 - CADstream: 2023-03-15 Standalone software application
• 00842000100003 - CADstream: 2021-09-29 Standalone Software Application