Segment CMR

GUDID 07350010100027

Software for cardiac image analysis.

Medviso AB

MRI system application software
Primary Device ID07350010100027
NIH Device Record Key3f1b17cd-f331-4d61-846b-dc64063eb17e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSegment CMR
Version Model Number2
Company DUNS554436829
Company NameMedviso AB
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350010100027 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-04-13

Devices Manufactured by Medviso AB

07350010100041 - Segment 3DPrint2023-11-08
07350010100010 - Segment2019-10-07 Software for medical image analysis.
07350010100027 - Segment CMR2018-07-06Software for cardiac image analysis.
07350010100027 - Segment CMR2018-07-06 Software for cardiac image analysis.

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