Merge PACS

GUDID 00842000101208

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation
Primary Device ID00842000101208
NIH Device Record Keybf6cc9cd-0a55-44a9-8587-46e472d015e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge PACS
Version Model Number9.3
Company DUNS065626069
Company NameMERGE HEALTHCARE SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842000101208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-28
Device Publish Date2025-08-20

On-Brand Devices [Merge PACS]

008420001007378.0
00842000100690Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adju
00842000100607Standalone software application
00842000100560Standalone software application
00842000100508Standalone software application
008420001004097.2
00842000100072Standalone software application
008420001008058.1
008420001004787.1.2.1
008420001009358.2
008420001010869.0
008420001011479.1
008420001011549.2
008420001012089.3

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