510(k) Report

Devices descending from K070675

8 later devices reach Mammaprint through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080252Modification to MammaprintAgendia BV200871
+2K081092Modification to MammaprintAgendia200961
+3K130010Prosigna (TM) Breast Cancer Prognostic Gene Signature AssayNanostring Technologies20131—
+3K101454MammaprintAgendia20113—
+4K141142Mammaprint FfpeAgendia20152—
+4K141771Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc.20140—
+5K201902MammaPrintAgendia, Inc.20201—
+6K210973MammaPrint FFPE NGS KitAgendia, Inc.20220—