Cleared Traditional

K181939 - icobrain
(FDA 510(k) Clearance)

K181939 · Icometrix NV · Radiology
Nov 2018
Decision
110d
Days
Class 2
Risk

K181939 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 November 6, 2018, 110 days after receiving the submission on July 19, 2018.

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

Submission Details

510(k) Number K181939 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2018
Decision Date November 06, 2018
Days to Decision 110 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