# K223646: IB Lab LAMA

- Pathway: 510(k) (Traditional)
- Applicant: Ib Lab GmbH
- Decided: Jun 16, 2023 after 192 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: 8 generations back to K942948 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192109: KOALA, Ib Lab GmbH (2019) Summary page 4.

## Most influential descendants
- K241593: BoneMetrics (US) (2025), 0 descendants of its own

## Indications for use
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology. IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.

Source page: https://510kreport.com/device/K223646
Methodology: https://510kreport.com/methodology