3mensio Workstation

GUDID 08056304455505

Pie Medical Imaging B.V.

Radiology DICOM image processing application software
Primary Device ID08056304455505
NIH Device Record Keyb3d70cd4-d77a-476b-8f93-95d97f9bcdb4
Commercial Distribution StatusIn Commercial Distribution
Brand Name3mensio Workstation
Version Model Number10.6
Company DUNS413761941
Company NamePie Medical Imaging B.V.
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31308500202
Emailsupport@pie.nl
Phone+31308500202
Emailsupport@pie.nl
Phone+31308500202
Emailsupport@pie.nl
Phone+31308500202
Emailsupport@pie.nl
Phone+31308500202
Emailsupport@pie.nl
Phone+31308500202
Emailsupport@pie.nl
Phone+31308500202
Emailsupport@pie.nl

Device Identifiers

Device Issuing AgencyDevice ID
GS108056304455505 [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 Date2024-04-15
Device Publish Date2024-04-05

On-Brand Devices [3mensio Workstation]

080563044542259.2
08056304454072Development ongoing
080563044512245.0
080563044512178.0
080563044538399.1
080563044537789.0
080563044534956.1
080563044534888.1
0805630445424910.1
0805630445466910.3
0805630445494210.4
0805630445434810.2
0805630445550510.6

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