FDA 510(k) Application Details - K211423

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K211423
Device Name	System, X-Ray, Mobile
Applicant	Micro-X Limited A14 6 Tonsley Boulevard Cloverly Park 5042 AU Other 510(k) Applications for this Company
Contact	Derek Rogers Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2021
Decision Date	05/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review