Name: Predicase
Price: 199 USD

K-number	K212960
Device name	Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Applicant	Canon Medical Systems Corporation
Product code	IYN
Device class	Class II
Decision date	Mar 22, 2022
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

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