AVIEW RT ACS— 510(k) K220408

Substantially Equivalent

Coreline Soft Co., Ltd.

FDA 510(k) clearance K220408 for AVIEW RT ACS, Substantially Equivalent on 2022-11-10. Applicant: Coreline Soft Co., Ltd..

Clearance details

Applicant: Coreline Soft Co., Ltd.
Product code: Code QKB
Advisory panel: Radiology
Date received: 2022-02-14
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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