510(k) Report

Devices descending from K213465

3 later devices reach CardioGraphe through their predicates, nearest generation first.

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