Cleared Traditional

K240712 - icobrain aria (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240712 · Icometrix NV · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
237d
Days
Class 2
Risk

K240712 is an FDA 510(k) clearance for the icobrain aria. Classified as Radiological Computer Assisted Detection/diagnosis Software For Fracture (product code QBS), Class II - Special Controls.

Submitted by Icometrix NV (Leuven, BE). The FDA issued a Cleared decision on November 7, 2024 after a review of 237 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2090 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Icometrix NV devices

Submission Details

510(k) Number K240712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 107d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBS Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QBS Radiological Computer Assisted Detection/diagnosis Software For Fracture

All 8
Devices cleared under the same product code (QBS) and FDA review panel - the closest regulatory comparables to K240712.
TechCare Trauma
K242171 · Milvue · Jan 2025
Rayvolve
K240845 · Azmed Sas · Jul 2024
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
K223491 · Ge Medical Systems, LLC · May 2023
BoneView
K222176 · Gleamer · Mar 2023
Rayvolve
K220164 · Azmed Sas · Jun 2022
BoneView
K212365 · Gleamer · Mar 2022