Cleared Traditional

icobrain aria

K240712 · Icometrix NV · Radiology
Nov 2024
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K240712 is an FDA 510(k) clearance for the icobrain aria, a Radiological Computer Assisted Detection/diagnosis Software For Fracture (Class II — Special Controls, product code QBS), submitted by Icometrix NV (Leuven, BE). The FDA issued a Cleared decision on November 7, 2024, 237 days after receiving the submission on March 15, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number K240712 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2024
Decision Date November 07, 2024
Days to Decision 237 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QBS — Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography, Mr, Ct). The Device Detects, Identifies And/or Characterizes Fracture Based On Features Or Information Extracted From Images, And May Provide Information About The Presence, Location, And/or Characteristics Of The Fracture To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.