FDA 510(k), K161382, LVivo Software Application

510(K) Number: K161382
Device Name: LVivo Software Application
Manufacturer: DIACARDIO, LTD.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 05/18/2016
Decision Date: 07/28/2016
Regulation Medical Specialty: Radiology

148 pages (461 of 609 original pages were fully redacted)