FDA 510(k) Application Details - K190420

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K190420
Device Name	System, Image Processing, Radiological
Applicant	Altaravision Inc. 130 Salem Town Court Apex, NC 27502 US Other 510(k) Applications for this Company
Contact	Stuart Bradley 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	02/21/2019
Decision Date	04/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review