510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QHAClass II

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

21 CFR 892.1600 / Radiology
FDA source (opens on fda.gov)

QHA is the FDA product code for X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, a class II device type, regulated under 21 CFR 892.1600. FDA's definition for this code reads: "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...". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QHA
Device name
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
FDA 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.
Regulation
21 CFR 892.1600
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code QHA

By decision year
7 clearances under product code QHA with a decision year between 2019 and 2025, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QHA by decision year
YearClearances
20191
20211
20232
20241
20252

Applicants with the most clearances

Product code QHA
Applicants holding the most 510(k) clearances under product code QHA
ApplicantClearances
ArteryFlow Technology Co., Ltd.3
Medis Medical Imaging Systems, B.V.1
PIE Medical Imaging B.V.1
QFR Solutions BV1
Spectrawave, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code