# K192109: KOALA

- Pathway: 510(k) (Traditional)
- Applicant: Ib Lab GmbH
- Decided: Nov 5, 2019 after 92 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 7 generations back to K942948 (1995). 10 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172327: VMA™ System version 3.0, Ortho Kinematics, Inc. (2017) Summary page 4.

## Most influential descendants
- K203696: RBknee (2021), 2 descendants of its own
- K223621: DeepXray (2023), 1 descendant of its own
- K223646: IB Lab LAMA (2023), 1 descendant of its own
- K253172: MediAI-OA (2026), 0 descendants of its own
- K241593: BoneMetrics (US) (2025), 0 descendants of its own

## Indications for use
IB Lab KOALA is a radiological fully-automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.

Source page: https://510kreport.com/device/K192109
Methodology: https://510kreport.com/methodology