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510(k) K242808

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 by Canon Medical Systems Corporation — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2025
Date Received
September 17, 2024
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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