510(k) Report

Devices descending from K213715

4 later devices reach Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253560Enhanced Boundary for PCCTGe Medical Systems, LLC20260—
+1K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC20260—
+1K250941Revolution VibeGe Medical Systems, LLC20250—
+1K233750ECG-less CardiacGe Medical Systems, LLC20240—