510(k) Report

Devices descending from K172110

4 later devices reach ECHELON OVAL V6.0A MRI System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation20233—
+2K233687ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation20242—
+3K241429ECHELON Synergy MRI SystemFujifilm Healthcare Corporation20241—
+4K251386ECHELON SynergyFujifilm Corporation20250—