Qangio XA 3D— 510(k) K182611

Substantially Equivalent

Medis Medical Imaging Systems BV

FDA 510(k) clearance K182611 for Qangio XA 3D, Substantially Equivalent on 2019-05-30. Applicant: Medis Medical Imaging Systems BV. Device class: 2.

Clearance details

Applicant
Medis Medical Imaging Systems BV
Product code
Code QHA
Device class
Class 2
Regulation
21 CFR 892.1600
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Leiden, NL
Download summary PDFView on FDA.gov ↗

Recent devices under product code QHA

view all

More clearances from Medis Medical Imaging Systems BV

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.