510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182611Substantially Equivalent

Qangio XA 3D

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

K182611 is the FDA 510(k) clearance record for Qangio XA 3D, a class II device, cleared for Medis Medical Imaging Systems 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 18 510(k) clearances for Medis Medical Imaging Systems BV, from to . As of , FDA records show no recalls naming K182611.

Clearance record

Decision date
Received
(251 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
Medis Medical Imaging Systems BV Schuttersveld 9, Leiden, 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