510(k) Report

Devices descending from K113145

10 later devices reach Echelon Oval Mri System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151015ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc.201561
+1K142734TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc.20152—
+2K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.20160—
+2K160152Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.20160—
+2K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.201652
+3K172110ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation201841
+4K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation20233—
+5K233687ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation20242—
+6K241429ECHELON Synergy MRI SystemFujifilm Healthcare Corporation20241—
+7K251386ECHELON SynergyFujifilm Corporation20250—