Name: Predicase
Price: 199 USD

K-number	K241582
Device name	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Applicant	Canon Medical Systems Corporation
Product code	IYN
Device class	Class II
Decision date	Sep 12, 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/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

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