K242994

Substantially Equivalent

OncoStudio (OS-01)

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

Download summary PDF View on FDA.gov ↗

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