510(k) Report

Devices descending from K071506

5 later devices reach Echelon Spectroscopy Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093044Oasis Mri SystemHitachi Medical Systems America, Inc.201041
+2K192851OASIS MRI SystemHitachi Healthcare Americas20203—
+3K202030OASIS MRI SystemHitachi Healthcare Americas202021
+4K211406OASIS MRI SystemHitachi Healthcare Americas20211—
+5K240571OASIS MRI SystemFujifilm Healthcare Corporation20240—