Cleared Traditional

K232147 - CAAS Workstation (FDA 510(k) Clearance)

K232147 · Pie Medical Imaging BV · Radiology device
Apr 2024
Decision
265d
Days
Class 2
Risk

K232147 is an FDA 510(k) clearance for the CAAS Workstation. This device is classified as a X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device (Class II - Special Controls, product code QHA).

Submitted by Pie Medical Imaging BV (Maastricht, NL). The FDA issued a Cleared decision on April 9, 2024, 265 days after receiving the submission on July 19, 2023.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician..

Submission Details

510(k) Number K232147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2023
Decision Date April 09, 2024
Days to Decision 265 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QHA — X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1600
Definition X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician.