Merge OrthoPACS

GUDID 00842000100454

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 ID00842000100454
NIH Device Record Key3e39de3e-d08d-4159-92db-2aeedaa51bec
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge OrthoPACS
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
GS100842000100454 [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 OrthoPACS]

008420001007758.0
008420001007067.3
00842000100577Standalone software application
00842000100348Standalone software application
00842000100089Standalone software application.
008420001006767.2
008420001004547.1.2.1
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