Data / Medical devices / Belgium / icometrix

icometrix: FDA-registered device maker in Leuven Vlaams Brabant, Belgium, 6 510(k) clearances

Name: icometrix FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

icometrix is registered with the FDA (registration 3013427569) in Leuven Vlaams Brabant, Belgium. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 7, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013427569
Address: Kolonel Begaultlaan 1b / 12, Leuven Vlaams Brabant, Belgium, 3012
Owner or operator: icometrix (10052535)
Roles: Manufacturer
First device listed: August 12, 2016
Registered through: 2026
Brand names listed: Concurrent supervision portal, icobrain aria, icobrain ct, icobrain ctp, icobrain mr, icompanion

Devices it lists

Device	Product code	Class	Role	Source
Radiological Computer Assisted Detection/Diagnosis Software For Fracture	QBS	2	Manufacturer	accessdata.fda.gov
Reminder, Medication	NXQ	1	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 7, 2024	K240712	icobrain aria	QBS	Substantially Equivalent	Icometrix NV	accessdata.fda.gov
February 28, 2020	K192962	icobrain-ctp	LLZ	Substantially Equivalent	Icometrix NV	accessdata.fda.gov
December 13, 2019	K192130	Icobrain	LLZ	Substantially Equivalent	Icometrix NV	accessdata.fda.gov
November 6, 2018	K181939	icobrain	LLZ	Substantially Equivalent	Icometrix NV	accessdata.fda.gov
March 8, 2018	K180326	icobrain	LLZ	Substantially Equivalent	Icometrix	accessdata.fda.gov
August 9, 2016	K161148	icobrain	LLZ	Substantially Equivalent	Icometrix	accessdata.fda.gov

Compare with other makers

Updated November 7, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.