MediAI-OA— 510(k) K253172

Name: FDA 510(k) clearance K253172
Creator: U.S. Food and Drug Administration
Published: 2026-06-15

Substantially Equivalent

Crescom Co., Ltd.

FDA 510(k) clearance K253172 for MediAI-OA, Substantially Equivalent on 2026-06-15. Applicant: Crescom Co., Ltd.. Device class: 2.

Summary

MediAI-OA from Crescom is filed under QIH, automated radiological image processing software. The record doesn't expand "OA" or describe the processing it performs.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Crescom filed from Seongnam-Si, South Korea. Review took 262 calendar days (September 26, 2025 to June 15, 2026).

Clearance details

Applicant: Crescom Co., Ltd.
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-09-26
Decision date: 2026-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.