510(k) Report

Devices descending from K081092

6 later devices reach Modification to Mammaprint through their predicates, nearest generation first.

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