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510(k) K230355

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR by Canon Medical Systems Corporation — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2023
Date Received
February 9, 2023
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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  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)
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