# K253172: MediAI-OA

- Pathway: 510(k) (Traditional)
- Applicant: Crescom Co., Ltd.
- Decided: Jun 15, 2026 after 262 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: 10 generations back to K942948 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223621: DeepXray, Alpha Intelligence Manifolds, Inc. (2023) Summary page 5.

## Indications for use
MediAI-OA 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 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/K253172
Methodology: https://510kreport.com/methodology