K251203

Substantially Equivalent

AVIEW Lung Nodule CAD

Applicant: Coreline Soft Co., Ltd.
Product code: OEB
Advisory panel: Radiology
Date received: 2025-04-18
Decision date: 2025-12-03
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.