K-number	K233992
Device name	Precision AI Surgical Planning System (PAI-SPS)
Applicant	Precision AI Pty, Ltd.
Product code	QHE
Device class	Class II
Decision date	Aug 5, 2024
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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Precision AI Surgical Planning System (PAI-SPS)

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