510(k) Report

Devices descending from DEN170058

6 later devices reach MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260235CellDx-TissueDatar Cancer Genetics Private Limited20260—
+1K241868xR IVDTempus AI, Inc.20250—
+1K210017ACTOnco, ACTOnco IVDAct Genomics20220—
+1K192063PGDx elio tissue completePersonal Genome Diagnostics20201—
+1K190661Omics CoreNanthealth, Inc.20190—
+2K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.20250—