Name: Predicase
Price: 199 USD

K-number	K233195
Device name	Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
Applicant	Canon Medical Systems Corporation
Product code	IYN
Device class	Class II
Decision date	Jan 24, 2024
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

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