Name: Predicase
Price: 199 USD

K-number	K231378
Device name	Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
Applicant	Insightec, Ltd.
Product code	PLP
Device class	Class II
Decision date	Oct 30, 2023
Decision	Substantially Equivalent
Regulation	876.4340

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Source

View the full FDA submission: accessdata.fda.gov

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Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

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