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510(k) K241429

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2024
Date Received
May 21, 2024
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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