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510(k) K223426

ECHELON Synergy MRI system by Fujifilm Healthcare Corporation — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2023
Date Received
November 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Fujifilm Healthcare Corporation

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  • K213829 — SCENARIA View (May 23, 2022)
  • K220295 — ARIETTA 50 (April 29, 2022)

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