CAAS MR 4D Flow

GUDID 08056304453051

Pie Medical Imaging B.V.

Radiology DICOM image processing application software
Primary Device ID08056304453051
NIH Device Record Key0e0d373c-df05-49c3-8d50-332022993138
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAAS MR 4D Flow
Version Model Number1.1
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108056304453051 [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 Date2019-10-07
Device Publish Date2017-01-18

On-Brand Devices [CAAS MR 4D Flow]

080563044530511.1
080563044534332.0

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