Cleared Traditional

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

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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

Submitted by Pie Medical Imaging BV (Maastricht, NL). The FDA issued a Cleared decision on April 9, 2024 after a review of 265 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 107d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QHA X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.