Name: Predicase
Price: 199 USD

K-number	K223864
Device name	Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Applicant	Brainlab AG
Product code	HAW
Device class	Class II
Decision date	Sep 9, 2023
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

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