OncoStudio (OS-01)— 510(k) K242994

Substantially Equivalent

Oncosoft. Co., Ltd.

FDA 510(k) clearance K242994 for OncoStudio (OS-01), Substantially Equivalent on 2025-02-24. Applicant: Oncosoft. Co., Ltd..

Clearance details

Applicant: Oncosoft. Co., Ltd.
Product code: Code QKB
Advisory panel: Radiology
Date received: 2024-09-26
Decision date: 2025-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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