FDA 510(k) Application Details - K182310

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K182310
Device Name	System, Image Processing, Radiological
Applicant	Volpara Health Technologies Limited Level 7, 44 Victoria Street, Wellington Central Wellington 6011 NZ Other 510(k) Applications for this Company
Contact	Ralph Highnam 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	08/24/2018
Decision Date	09/21/2018
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