RCT700— 510(k) K251798

Substantially Equivalent

Ray Co., Ltd.

FDA 510(k) clearance K251798 for RCT700, Substantially Equivalent on 2025-11-25. Applicant: Ray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ray Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2025-06-12
Decision date: 2025-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-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.