CAAS MR Solutions

GUDID 08056304453969

Pie Medical Imaging B.V.

Radiology DICOM image processing application software
Primary Device ID08056304453969
NIH Device Record Key315c0970-67b2-4e82-9ad2-931f931b5601
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAAS MR Solutions
Version Model Number5.0
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
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
GS108056304453969 [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 Number2
Public Version Date2019-10-07
Device Publish Date2019-05-20

On-Brand Devices [CAAS MR Solutions]

080563044539695.0
08056304454041Development ongoing
08056304454706Text to be remove

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