# DEN180005: OsteoDetect

- Pathway: De Novo (Direct)
- Applicant: Imagen Technologies, Inc.
- Decided: May 24, 2018 after 108 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
No predicates in its family tree.
50 later devices descend from it; 4 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K181704: Transpara (2018), 32 descendants of its own
- K193229: Transpara (2020), 9 descendants of its own
- K193417: FractureDetect (FX) (2020), 8 descendants of its own
- K182373: PowerLook Tomo Detection V2 Software (2018), 7 descendants of its own
- K192287: Transpara (2019), 6 descendants of its own

## Indications for use
OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists.

Source page: https://510kreport.com/device/DEN180005
Methodology: https://510kreport.com/methodology