510(k) Report

Devices descending from K080961

12 later devices reach NM Application Suite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111731Molecular Breast Imaging SoftwareGamma Medica-Ideas Incorporated20110—
+1K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc.20119—
+1K111024Jetpack 2.0Philips Medical Systems (Cleveland), Inc.20110—
+2K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+2K151212Ziostation2Qi Imaging, LLC20152—
+3K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+3K210831OnQ NeuroCortechs Labs, Inc.20213—
+3K181892Ziostation2Ziosoft, Inc.20181—
+4K250416GBrain MRIGalileo Cds, Inc.20251—
+4K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+4K200315Ziostation2Ziosoft, Inc.20200—
+5K252362GBrain MRIGalileo Cds, Inc.20250—