# K222176: BoneView

- Pathway: 510(k) (Traditional)
- Applicant: Gleamer
- Decided: Mar 2, 2023 after 223 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: 3 generations back to DEN180005 (2018). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212365: BoneView, Gleamer (2022) Summary page 4.

## Most influential descendants
- K242171: TechCare Trauma (2025), 0 descendants of its own

## Indications for use
BoneView 1.1-US is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of: Ankle, foot, knee, tibia/fibula, wrist, hand, elbow, forearm, humerus, shoulder, and clavicle in adults and children/adolescents; and pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine in adults only. Compatible radiographic views are frontal, lateral, and/or oblique views as applicable to the study type. BoneView 1.1-US is intended for use as a concurrent reading aid during the interpretation of radiographs. BoneView 1.1-US is for prescription use only.

Source page: https://510kreport.com/device/K222176
Methodology: https://510kreport.com/methodology