510(k) Report

Devices descending from K951650

8 later devices reach Clinical Proton Spectroscopy Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073425Modification to Aurora Mri SystemAurora Imaging Technology, Inc.20080—
+1K991568MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc.19996—
+2K071506Echelon Spectroscopy PackageHitachi Medical Systems America, Inc.20075—
+3K093044Oasis Mri SystemHitachi Medical Systems America, Inc.201041
+4K192851OASIS MRI SystemHitachi Healthcare Americas20203—
+5K202030OASIS MRI SystemHitachi Healthcare Americas202021
+6K211406OASIS MRI SystemHitachi Healthcare Americas20211—
+7K240571OASIS MRI SystemFujifilm Healthcare Corporation20240—