FDA 510(k) Application Details - K230854

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K230854
Device Name	System, Image Processing, Radiological
Applicant	AIRS Medical Inc. 13-14F, Keungil Tower, 223, Teheran-ro Gangnam-gu Seoul 06142 KR Other 510(k) Applications for this Company
Contact	Jihyeon Seo Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2023
Decision Date	10/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review