Arterys, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252539Tempus PixelSeptember 3, 2025
K203744Arterys MICAMarch 14, 2022
K192437Arterys MICAMarch 25, 2020
K182034Arterys MICAOctober 17, 2018
K173542Arterys Oncology DLJanuary 25, 2018
K171544Arterys ViewerJuly 18, 2017
K163253Arterys Cardio DLJanuary 5, 2017
K162513Arterys Software v2.0October 28, 2016