Merge OrthoPACS

GUDID 00842000100577

Standalone software application

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 ID00842000100577
NIH Device Record Key80ad7385-6ffa-4719-8c1f-d4af74d72261
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge OrthoPACS
Version Model Number7.0.2
Company DUNS065626069
Company NameMERGE HEALTHCARE SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100842000100577 [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 Number5
Public Version Date2019-05-23
Device Publish Date2016-12-15

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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