bright CT— 510(k) K231181

Substantially Equivalent

Dentium Co., Ltd (Ict Branch)

FDA 510(k) clearance K231181 for bright CT, Substantially Equivalent on 2023-12-14. Applicant: Dentium Co., Ltd (Ict Branch). Device class: 2.

Clearance details

Applicant: Dentium Co., Ltd (Ict Branch)
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2023-04-26
Decision date: 2023-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Suwon-Si, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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