Merge OrthoPACS

GUDID 00842000100089

Standalone software application.

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software
Primary Device ID00842000100089
NIH Device Record Keyad5cba67-7c2b-49f5-8878-214491290a46
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge OrthoPACS
Version Model Number7.1.1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842000100089 [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 Date2017-02-10

On-Brand Devices [Merge OrthoPACS]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.