Arterys Inc.

6 AI-enabled medical devices from Arterys Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2025-09-03K252539Tempus PixelArterys, Inc.Radiology
2022-03-14K203744Arterys MICAArterys Inc.Radiology
2020-03-25K192437Arterys MICAArterys Inc.Radiology
2018-10-17K182034Arterys MICAArterys Inc.Radiology
2018-01-25K173542Arterys Oncology DLArterys Inc.Radiology
2017-01-05K163253Arterys Cardio DLARTERYS INC.Radiology

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