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510(k) K233334

Aquilion Serve SP (TSX-307B/1) V1.3 by Canon Medical Systems Corporation — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2023
Date Received
September 29, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
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