# K212365: BoneView

- Pathway: 510(k) (Traditional)
- Applicant: Gleamer
- Decided: Mar 1, 2022 after 214 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: 2 generations back to DEN180005 (2018). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193417: FractureDetect (FX), Imagen Technologies, Inc. (2020) Summary page 4.

## Most influential descendants
- K222176: BoneView (2023), 1 descendant of its own
- K242171: TechCare Trauma (2025), 0 descendants of its own
- K223491: Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (2023), 0 descendants of its own

## Indications for use
BoneView is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of: Study Type (Anatomical Area of Interest) Compatible Radiographic View(s) Ankle Frontal, Lateral, Oblique Foot Frontal, Lateral, Oblique Knee Frontal, Lateral Tibia/Fibula Frontal, Lateral Femur Frontal, Lateral Wrist Frontal, Lateral, Oblique Hand Frontal, Oblique Elbow Frontal, Lateral Forearm Frontal, Lateral Humerus Frontal, Lateral Shoulder Frontal, Lateral, Axillary Clavicle Frontal Pelvis Frontal Hip Frontal, Frog Leg Lateral Ribs Frontal Chest, Rib series Thoracic Spine Frontal, Lateral Lumbosacral Spine Frontal, Lateral BoneView is intended for use as a concurrent reading aid during the interpretations of radiographs. BoneView is for prescription use only and is indicated for adults only.

Source page: https://510kreport.com/device/K212365
Methodology: https://510kreport.com/methodology