# K242171: TechCare Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Milvue
- Decided: Jan 17, 2025 after 177 days
- Product code: QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222176: BoneView, Gleamer (2023) Summary page 7.

## Indications for use
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: 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.

Source page: https://510kreport.com/device/K242171
Methodology: https://510kreport.com/methodology