FDA 510(k) Applications Submitted by Arineta Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K161066 04/15/2016 SpotLight CT Arineta Ltd.
K241200 04/30/2024 SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option Arineta Ltd.
K230370 02/10/2023 SpotLight/SpotLight Duo (with DLIR option) Arineta Ltd.
K213465 10/28/2021 CardioGraphe Arineta Ltd.
K250650 03/04/2025 SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option Arineta Ltd.


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