510(k) Report

Devices descending from K991568

6 later devices reach MR Spectroscopy Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071506Echelon Spectroscopy PackageHitachi Medical Systems America, Inc.20075—
+2K093044Oasis Mri SystemHitachi Medical Systems America, Inc.201041
+3K192851OASIS MRI SystemHitachi Healthcare Americas20203—
+4K202030OASIS MRI SystemHitachi Healthcare Americas202021
+5K211406OASIS MRI SystemHitachi Healthcare Americas20211—
+6K240571OASIS MRI SystemFujifilm Healthcare Corporation20240—