# K193417: FractureDetect (FX)

- Pathway: 510(k) (Traditional)
- Applicant: Imagen Technologies, Inc.
- Decided: Jul 30, 2020 after 234 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: 1 generation back to DEN180005 (2018). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180005: OsteoDetect, Imagen Technologies, Inc. (2018) Summary page 4.

## Most influential descendants
- K220164: Rayvolve (2022), 3 descendants of its own
- K212365: BoneView (2022), 3 descendants of its own
- K240845: Rayvolve (2024), 2 descendants of its own
- K260378: Rayvolve (2026), 1 descendant of its own
- K222176: BoneView (2023), 1 descendant of its own

## Indications for use
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only. FX is indicated for radiographs of the following industry-standard radiographic views and study types. Study Type (Anatomic+Area of Interest) | Radiographic View(s) Supported* Ankle | Frontal, Lateral, Oblique Clavicle | Frontal Elbow | Frontal, Lateral Femur | Frontal, Lateral Forearm | Frontal, Lateral Hip | Frontal, Frog Leg Lateral Humerus | Frontal, Lateral Knee | Frontal, Lateral Pelvis | Frontal Shoulder | Frontal, Lateral, Axillary Tibia / Fibula | Frontal, Lateral Wrist | Frontal, Lateral, Oblique *For the purposes of this table, “Frontal” is considered inclusive of both posteroanterior (PA) and anteroposterior (AP) views. +Definitions of anatomic area of interest and radiographic views are consistent with the American College of Radiology (ACR) standards and guidelines.

Source page: https://510kreport.com/device/K193417
Methodology: https://510kreport.com/methodology