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510(k) K253597

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System by Canon Medical Systems Corporation — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2026
Date Received
November 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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Other clearances for product code IYN

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  • K250959 — BioticsAI (December 22, 2025)
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  • K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 (December 5, 2025)
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