CAAS Qardia

GUDID 08056304454768

Pie Medical Imaging B.V.

Radiology DICOM image processing application software
Primary Device ID08056304454768
NIH Device Record Key85017d32-b750-4582-a493-fa93534759e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAAS Qardia
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS108056304454768 [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 Date2023-12-04
Device Publish Date2023-01-13

On-Brand Devices [CAAS Qardia]

080563044549282.0
080563044547681.1
080563044553692.1

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