510(k) Report

Devices descending from K142032

4 later devices reach Mri Patient Monitoring System Tesla M3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1722003880 MRI Patient Monitoring SystemIradimed Corporation20172—
+1K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin20160—
+2K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+2K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—