rainbow CT— 510(k) K200271

Substantially Equivalent

Dentium Co., Ltd (Ict Branch)

FDA 510(k) clearance K200271 for rainbow CT, Substantially Equivalent on 2021-04-16. Applicant: Dentium Co., Ltd (Ict Branch).

Clearance details

Applicant: Dentium Co., Ltd (Ict Branch)
Product code: Code OAS
Advisory panel: Radiology
Date received: 2020-02-04
Decision date: 2021-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

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