Radiology · 510(k) · 2025
TechCare Trauma
Milvue. Cleared by FDA on 17 January 2025 under submission K242171, product code QBS (radiological computer assisted detection/diagnosis software for fracture). What FDA's record says, in FDA's words.
Device record · K242171
- Device. TechCare TraumaDEVICE
- Company. Milvue (FR)COMPANY
- Decision. 17 January 2025, 510(k), substantially equivalent (traditional review); received 24 July 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 (23 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.
TechCare Trauma is intended to analyze 2D X ray radiographs using machine learning techniques to aid in the detection, localization, and characterization of fractures and/or elbow joint effusion during the review of commonly acquired radiographs of: Table 1 : Intended Use Overview FORM FDA 3881 (8/23) PSC Publishing Services (301) 443-6740 EF TechCare Trauma can provide results for fracture in neonates and infants (from birth to less than 2 years), children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over). TechCare Trauma can provide results for elbow joint effusions in children and adolescents (aged 2 to less than 22 years) and adults (aged 22 years and over). The intended users of TechCare Trauma are clinicians with the authority to diagnose fractures and/or elbow joint effusions in various settings including primary care ( e. g., family practice, internal medicine), emergency medicine, urgent care, and specialty care (e. g. orthopedics), as well as radiologists who review radiographs across settings. TechCare Trauma results are not intended to be used on a stand-alone basis for clinical decision-making. Primary diagnostic and patient management decisions are made by the clinical user.
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.
- Modalities namedradiographs (X-ray)
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
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 Milvue, or cleared in 2025. 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.