K-number	K211269
Device name	Visualase MRI-Guided Laser Ablation System (SW 3.4)
Applicant	Medtronic Navigation, Inc.
Product code	ONO
Device class	Class II
Decision date	Jan 7, 2022
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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Visualase MRI-Guided Laser Ablation System (SW 3.4)

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