510(k) Report

Devices descending from K153547

5 later devices reach ECHELON Oval V 5.1 MRI System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172110ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation201841
+2K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation20233—
+3K233687ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation20242—
+4K241429ECHELON Synergy MRI SystemFujifilm Healthcare Corporation20241—
+5K251386ECHELON SynergyFujifilm Corporation20250—