# K203696: RBknee

- Pathway: 510(k) (Traditional)
- Applicant: Radiobotics Aps
- Decided: Aug 27, 2021 after 252 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: 8 generations back to K942948 (1995). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 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 5.

## Most influential descendants
- K223621: DeepXray (2023), 1 descendant of its own
- K253172: MediAI-OA (2026), 0 descendants of its own

## Indications for use
RBknee 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 on 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/K203696
Methodology: https://510kreport.com/methodology