Radiology · 510(k) · 2024
icobrain aria
icometrix NV. Cleared by FDA on 7 November 2024 under submission K240712, product code QBS (radiological computer assisted detection/diagnosis software for fracture). What FDA's record says, in FDA's words.
Device record · K240712
- Device. icobrain ariaDEVICE
- Company. icometrix NV (BE)COMPANY
- Decision. 7 November 2024, 510(k), substantially equivalent (traditional review); received 15 March 2024DECISION
- Panel. RadiologyPANEL
- Product code. QBS, Radiological Computer Assisted Detection/Diagnosis Software For FractureCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
of icobrain aria and the predicate device differ in the disease-specific findings the devices detect, the type of medical images the devices process, and the intended patient population. However, these differences should not raise new questions regarding safety and effectiveness of the device when used as labeled, under the same general and special controls as the
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QBS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QBS, in Radiology, from icometrix NV, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.