Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 FDA decision2025-09-03
TypeNumberDevice NameCodeDateActions
510(k) K252539 Tempus PixelQIH2025-09-03 View
510(k) K203744 Arterys MICAQIH2022-03-14 View
510(k) K192437 Arterys MICAQIH2020-03-25 View
510(k) K182034 Arterys MICALLZ2018-10-17 View
510(k) K173542 Arterys Oncology DLLLZ2018-01-25 View
510(k) K171544 Arterys ViewerLLZ2017-07-18 View
510(k) K163253 Arterys Cardio DLLLZ2017-01-05 View
510(k) K162513 Arterys Software v2.0LLZ2016-10-28 View