Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Arterys, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest Approval2025-09-03
TypeNumberDevice NameCodeDate
510(k) K252539 Tempus Pixel QIH 2025-09-03 View
510(k) K203744 Arterys MICA QIH 2022-03-14 View
510(k) K192437 Arterys MICA QIH 2020-03-25 View
510(k) K182034 Arterys MICA LLZ 2018-10-17 View
510(k) K173542 Arterys Oncology DL LLZ 2018-01-25 View
510(k) K171544 Arterys Viewer LLZ 2017-07-18 View
510(k) K163253 Arterys Cardio DL LLZ 2017-01-05 View
510(k) K162513 Arterys Software v2.0 LLZ 2016-10-28 View
↑