Merge Cardio

GUDID 00842000100928

Standalone software application

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software
Primary Device ID00842000100928
NIH Device Record Keya4e892e2-12f2-4785-be96-c3a1fcb8ee6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge Cardio
Version Model Number12.1
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
GS100842000100928 [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 Date2021-09-29
Device Publish Date2021-09-21

On-Brand Devices [Merge Cardio]

00842000100591Standalone software application
00842000100416Standalone software application
00842000100041Standalone software application.
0084200010076812.0.1
00842000100928Standalone software application
00842000101123Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascu

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