FDA 510(k) Application Details - K181964

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K181964
Device Name	System, Image Processing, Radiological
Applicant	Visus Health IT GmbH Gesundheitscampus-Sued 15-17 Bochum 44801 DE Other 510(k) Applications for this Company
Contact	Axel Schreiber 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	07/23/2018
Decision Date	10/23/2018
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