Cleared Traditional

K192130 - Icobrain
(FDA 510(k) Clearance)

K192130 · Icometrix NV · Radiology
Dec 2019
Decision
128d
Days
Class 2
Risk

K192130 is an FDA 510(k) clearance for the Icobrain. 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 December 13, 2019, 128 days after receiving the submission on August 7, 2019.

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

Submission Details

510(k) Number K192130 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2019
Decision Date December 13, 2019
Days to Decision 128 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