Cleared Traditional

K192962 - icobrain-ctp
(FDA 510(k) Clearance)

K192962 · Icometrix NV · Radiology
Feb 2020
Decision
129d
Days
Class 2
Risk

K192962 is an FDA 510(k) clearance for the icobrain-ctp. This device is classified as a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ).

Submitted by Icometrix NV (Leuven, BE). The FDA issued a Cleared decision on February 28, 2020, 129 days after receiving the submission on October 22, 2019.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K192962 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2019
Decision Date February 28, 2020
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050