510(k) Report

Devices descending from K083533

11 later devices reach Echelon C Mri System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113145Echelon Oval Mri SystemHitachi Medical Systems America, Inc.2012103
+2K151015ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc.201561
+2K142734TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc.20152—
+3K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.20160—
+3K160152Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.20160—
+3K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.201652
+4K172110ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation201841
+5K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation20233—
+6K233687ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation20242—
+7K241429ECHELON Synergy MRI SystemFujifilm Healthcare Corporation20241—
+8K251386ECHELON SynergyFujifilm Corporation20250—