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FDA 510(k) Applications for Medical Device Product Code "QHA"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K210093
ArteryFlow Technology Co., Ltd.
AccuFFRangio
09/10/2021
K230303
ArteryFlow Technology Co., Ltd.
AccuFFRangio Plus
03/02/2023
K221711
ArteryFlow Technology Co., Ltd.
AccuICAS
02/28/2023
K182611
Medis Medical Imaging Systems bv
Qangio XA 3D
05/30/2019
K232147
Pie Medical Imaging B.V.
CAAS Workstation
04/09/2024
K243769
QFR Solutions bv
QFR (3.0)
04/04/2025
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