# K223621: DeepXray

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Intelligence Manifolds, Inc.
- Decided: Sep 8, 2023 after 277 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.
1 later device descends 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 4.
- K203696: RBknee, Radiobotics Aps (2021) Summary page 4.

## Most influential descendants
- K253172: MediAI-OA (2026), 0 descendants of its own

## Indications for use
DeepXray 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, orthopedists, physicians and medical technicians.

Source page: https://510kreport.com/device/K223621
Methodology: https://510kreport.com/methodology