Arterys, Inc. is one of 16108 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Arterys, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Tempus Pixel, Arterys MICA, Arterys MICA
8
Total
8
Cleared
0
Denied
Arterys, Inc. has 8 FDA 510(k) cleared medical devices. Based in San Francisco, US.
Latest FDA clearance: Sep 2025. Active since 2016. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Arterys, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Arterys, Inc.
8 devices
Cleared
Sep 03, 2025
Tempus Pixel
Radiology
22d
Cleared
Mar 14, 2022
Arterys MICA
Radiology
447d
Cleared
Mar 25, 2020
Arterys MICA
Radiology
201d
Cleared
Oct 17, 2018
Arterys MICA
Radiology
79d
Cleared
Jan 25, 2018
Arterys Oncology DL
Radiology
70d
Cleared
Jul 18, 2017
Arterys Viewer
Radiology
53d
Cleared
Jan 05, 2017
Arterys Cardio DL
Radiology
48d
Cleared
Oct 28, 2016
Arterys Software v2.0
Radiology
50d