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510(k) K250901

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR by Canon Medical Systems Corporation — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2025
Date Received
March 26, 2025
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

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