Cleared Special

K230303 - AccuFFRangio Plus (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230303 · ArteryFlow Technology Co., Ltd. · Radiology device
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Mar 2023
Decision
27d
Days
Class 2
Risk

K230303 is an FDA 510(k) clearance for the AccuFFRangio Plus. Classified as X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device (product code QHA), Class II - Special Controls.

Submitted by ArteryFlow Technology Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on March 2, 2023 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ArteryFlow Technology Co., Ltd. devices

Submission Details

510(k) Number K230303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2023
Decision Date March 02, 2023
Days to Decision 27 days
Submission Type Special
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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - QHA X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

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