FDA 510(k) Application Details - K243411

Device Classification Name	More FDA Info for this Device
510(K) Number	K243411
Device Name	Diagnostic X-ray System
Applicant	Nanjing Perlove Medical Equipment Co., Ltd. No. 97 and No. 99 Wangxi Road, Jiangning District Nanjing 211100 CN Other 510(k) Applications for this Company
Contact	Fengfang Lu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2024
Decision Date	05/19/2025
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