CAAS MR Flow

GUDID 08056304451170

Pie Medical Imaging B.V.

Radiology DICOM image processing application software
Primary Device ID08056304451170
NIH Device Record Keyffcd06a2-629d-46cf-a0bd-e242a210dcba
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAAS MR Flow
Version Model Number1.0
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
GS108056304451170 [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 Date2016-09-27

Devices Manufactured by Pie Medical Imaging B.V.

08056304455772 - CAAS Workstation2024-08-30
08056304455505 - 3mensio Workstation2024-04-15
08056304454706 - CAAS MR Solutions2023-12-29 Text to be remove
08056304455369 - Caas Qardia2023-12-28
08056304454256 - CAAS MR Solution2023-12-04
08056304454270 - CAAS A-Valve2023-12-04
08056304454348 - 3mensio Workstation 2023-12-04
08056304454768 - CAAS Qardia2023-12-04

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