Name: Predicase
Price: 199 USD

K-number	K192703
Device name	Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
Applicant	Brainlab AG
Product code	HAW
Device class	Class II
Decision date	Oct 8, 2020
Decision	Substantially Equivalent
Regulation	882.4560

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

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