Name: Predicase
Price: 199 USD

K-number	K252074
Device name	Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
Applicant	Canon Medical Systems Corporation
Product code	IYN
Device class	Class II
Decision date	Oct 31, 2025
Decision	Substantially Equivalent
Regulation	892.1550

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

Everything you need for a 510(k) submission. Nothing you don't.