Radiology

AI Fracture Detection Software

Marks possible broken bones on an X-ray, aimed at the ones that get missed on a busy night.

11 products cleared under FDA code QBS, from May 24, 2018 to August 28, 2026. Checked September 25, 2026.

A narrow job with an unusually clear case for existing.

Missed fractures are one of the most common errors in emergency imaging, and they cluster in predictable places: small wrist bones, hips in older patients, ribs, and anything read at three in the morning by someone on hour eleven.

These products mark suspected breaks so a second look happens before the patient goes home. The appeal is not that the software is cleverer than the doctor. It is that the software is equally awake at every hour.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
QBS
FDA name for it
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Rule number
21 CFR 892.2090
Risk class
Class 2
Medical field
Radiology
The FDA's own wording: 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.

Before You Sign Anything

  • Ask which bones it was cleared on. Fracture AI is usually far better on some sites than others, and the gap is not small.
  • Ask about paediatric imaging specifically. Growth plates confuse models that were trained mostly on adults.
  • Ask whether it runs before or after the first read. Catching a miss is worth more than confirming a hit.

Who Holds the Most Clearances Here

CompanyCleared products
AZmed2
Azmed Sas2
Gleamer2
Imagen Technologies, Inc.2
Milvue1
Icometrix NV1
Ge Medical Systems, LLC1

Every Cleared Product, Newest First

Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.

ProductCompanyClearedFDA record
Rayvolve AZchest AZmed August 28, 2026 K261378
Rayvolve AZmed May 12, 2026 K260378
TechCare Trauma Milvue January 17, 2025 K242171
icobrain aria Icometrix NV November 7, 2024 K240712
Rayvolve Azmed Sas July 17, 2024 K240845
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite Ge Medical Systems, LLC May 25, 2023 K223491
BoneView Gleamer March 2, 2023 K222176
Rayvolve Azmed Sas June 2, 2022 K220164
BoneView Gleamer March 1, 2022 K212365
FractureDetect (FX) Imagen Technologies, Inc. July 30, 2020 K193417
OsteoDetect Imagen Technologies, Inc. May 24, 2018 DEN180005

Other Radiology Device Types

Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.