K251483

Substantially Equivalent

SwiftSight-Brain

Applicant: Airs Medical, Inc.
Product code: QIH
Advisory panel: Radiology
Date received: 2025-05-14
Decision date: 2025-09-23
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.