510(k) Report

Devices descending from K161066

4 later devices reach SpotLight CT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213465CardioGrapheArineta, Ltd.20223—
+2K230370SpotLight/SpotLight Duo (with DLIR option)Arineta, Ltd.20232—
+3K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20251—
+4K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20250—