Medical Device Manufacturer · US , San Francisco , CA

Arterys, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2016
8
Total
8
Cleared
0
Denied

FDA 510(k) cleared devices by Arterys, Inc. Radiology ✕

8 devices
1-8 of 8
Cleared Sep 03, 2025
Tempus Pixel
K252539 · QIH
Radiology · 22d
Cleared Mar 14, 2022
Arterys MICA
K203744 · QIH
Radiology · 447d
Cleared Mar 25, 2020
Arterys MICA
K192437 · QIH
Radiology · 201d
Cleared Oct 17, 2018
Arterys MICA
K182034 · LLZ
Radiology · 79d
Cleared Jan 25, 2018
Arterys Oncology DL
K173542 · LLZ
Radiology · 70d
Cleared Jul 18, 2017
Arterys Viewer
K171544 · LLZ
Radiology · 53d
Cleared Jan 05, 2017
Arterys Cardio DL
K163253 · LLZ
Radiology · 48d
Cleared Oct 28, 2016
Arterys Software v2.0
K162513 · LLZ
Radiology · 50d
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