FDA 510(k) Application Details - K221499

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K221499
Device Name	System, Image Processing, Radiological
Applicant	Augment Intelligent Medical System (China) Co., Ltd. 1801-1812,Floor18,Block B,Kechuang No.1 Building,No.320 Pubin Road,Jiangpu Sub-District,Pukou Nanjing 211808 CN Other 510(k) Applications for this Company
Contact	Chen Lihong 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	05/23/2022
Decision Date	11/22/2022
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