# K241593: BoneMetrics (US)

- Pathway: 510(k) (Traditional)
- Applicant: Gleamer Sas
- Decided: Feb 5, 2025 after 247 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K942948 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223646: IB Lab LAMA, Ib Lab GmbH (2023) Summary page 5.

## Indications for use
BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is to be used by healthcare professionals trained in radiology.

Source page: https://510kreport.com/device/K241593
Methodology: https://510kreport.com/methodology