510(k) Report

Devices descending from K151015

6 later devices reach ECHELON Oval V 5.0 MRI System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.201652
+2K172110ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation201841
+3K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation20233—
+4K233687ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation20242—
+5K241429ECHELON Synergy MRI SystemFujifilm Healthcare Corporation20241—
+6K251386ECHELON SynergyFujifilm Corporation20250—