Segment 3DPrint

GUDID 07350010100041

Medviso AB

Image segmentation application software
Primary Device ID07350010100041
NIH Device Record Key88d3f1db-cfc3-498f-a4db-2cf54eb8c013
Commercial Distribution StatusIn Commercial Distribution
Brand NameSegment 3DPrint
Version Model Number1
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 Batchfalse
Serial Numbertrue
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
GS107350010100041 [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 Date2023-11-08
Device Publish Date2023-10-31

Devices Manufactured by Medviso AB

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

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