510(k) Report

Devices descending from K022001

9 later devices reach Mpower, Model 712 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090178Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C…Neusoft Positron Medical Systems Co., Ltd.20097—
+1K061587Fullcard AnalysisGE Healthcare20061—
+2K192277CardIQ FlowGE Medical Systems SCS20200—
+2K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+3K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+4K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+4K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+5K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+6K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—