FDA 510(k) Application Details - K193369

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K193369
Device Name	System, Image Processing, Radiological
Applicant	Infinitt Healthcare Co.,Ltd. 12F Daerung Post Tower III, 27 Digital-ro 34-gil Seoul 08378 KR Other 510(k) Applications for this Company
Contact	Sang Wook Cho 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	12/05/2019
Decision Date	04/14/2020
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