510(k) Report

Devices descending from K223426

3 later devices reach ECHELON Synergy MRI system through their predicates, nearest generation first.

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