510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K232147Substantially Equivalent

CAAS Workstation

PIE Medical Imaging B.V., Maastricht, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232147 is the FDA 510(k) clearance record for CAAS Workstation, a class II device, cleared for Pie Medical Imaging BV on under FDA product code QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device). FDA's definition for product code QHA 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...". FDA records list 24 510(k) clearances for Pie Medical Imaging BV, from to . As of , FDA records show no recalls naming K232147.

Clearance record

Decision date
Received
(265 days to decision)
Product code
QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Regulation
21 CFR 892.1600
Device class
Class II
Review panel
Radiology
Applicant
Pie Medical Imaging BV Philipsweg 1, Maastricht, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QHA

Trailing 12 months

FDA records hold no clearances under product code QHA in the trailing twelve months.

FDA records show no clearances under product code QHA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QHA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260