Class Class II
ECHELON Synergy MRI System (K241429)
Description
ECHELON Synergy MRI System by Fujifilm Healthcare Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241429
Clearance Date2024-08-13
Clearance TypeTraditional
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241429
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ECHELON Synergy MRI System (K241429) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233687 | ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corpor... | 2024 |
Trace the full predicate network for K241429
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.