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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K212376
Device Name Caas Qardia
Applicant
Pie Medical Imaging BV
Philipsweg 1
Maastricht,  NL 6227 AJ
Applicant Contact Annemiek Bouts
Correspondent
Pie Medical Imaging BV
Philipsweg 1
Maastricht,  NL 6227 AJ
Correspondent Contact Annemiek Bouts
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/30/2021
Decision Date 05/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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