510(k) Report

Devices descending from K201298

8 later devices reach VX1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250749PhysCade SystemPhyscade, Inc.20250—
+1K232616Volta AF-XplorerVolta Medical20232—
+1K223516VX1+Volta Medical20234—
+1K220786STAR Apollo Mapping SystemRhythm Al, Ltd.20220—
+1K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+2K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+2K243812Volta AF-XplorerVolta Medical20251—
+3K251518Volta AF-Xplorer IIVolta Medical20250—