K250780

Substantially Equivalent

ARTAssistant

Applicant: Manteia Technologies Co., Ltd.
Product code: QKB
Advisory panel: Radiology
Date received: 2025-03-14
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

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