FDA 510(k) Application Details - K222036

Device Classification Name	More FDA Info for this Device
510(K) Number	K222036
Device Name	MPXA-2000
Applicant	Medipixel, Inc. Dooam Building 7F, 61, Yangwha-ro, Mapo-gu, Seoul, Republic of Korea Seoul 04037 KR Other 510(k) Applications for this Company
Contact	Hye-ri Choi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2022
Decision Date	03/22/2023
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