RadSuite

GUDID 00842000100614

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00842000100614
• NIH Device Record Key: 02a74744-f180-4c06-a1c8-b4fbefb1230e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RadSuite
• Version Model Number: 8.32
• 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	00842000100614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053281

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: 2019-10-03
• Device Publish Date: 2019-09-25

Devices Manufactured by MERGE HEALTHCARE SOLUTIONS INC.

• 00842000101079 - Merge Hemo: 2024-09-18
• 00842000101154 - Merge PACS: 2024-07-09
• 00842000101161 - Merge Universal Viewer: 2024-05-08
• 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