FDA 510(k) Application Details - K240841

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K240841
Device Name	System, X-Ray, Mobile
Applicant	Shenzhen Browiner Tech Co., Ltd Rm 501, Bldg C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Rd, Yangguang Community, Xili Street Shenzhen 518055 CN Other 510(k) Applications for this Company
Contact	Li Chen 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	03/27/2024
Decision Date	12/09/2024
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