Merge PACS

GUDID 00842000100478

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software
Primary Device ID00842000100478
NIH Device Record Key39398dea-159c-4687-af68-8ac79aac8885
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge PACS
Version Model Number7.1.2.1
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842000100478 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-23
Device Publish Date2019-05-13

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

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