Novarad Corporation

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2956-2020Class IINovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that rSeptember 10, 2019
Z-2659-2016Class IINovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving andAugust 12, 2016
Z-1613-2016Class IINovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad CorporationNovember 16, 2015
Z-2151-2016Class IINovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. PMay 9, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K220146VisARMay 27, 2022
K172418OpenSightSeptember 21, 2018
K171754NovaPACSJuly 28, 2017
K160371NovaPACSOctober 14, 2016