510(k) Report

Devices descending from K191777

5 later devices reach Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC2021411
+2K253560Enhanced Boundary for PCCTGe Medical Systems, LLC20260—
+2K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC20260—
+2K250941Revolution VibeGe Medical Systems, LLC20250—
+2K233750ECG-less CardiacGe Medical Systems, LLC20240—