Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0— 510(k) K231378

Substantially Equivalent

Insightec, Ltd.

FDA 510(k) clearance K231378 for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0, Substantially Equivalent on 2023-10-30. Applicant: Insightec, Ltd..

Clearance details

Applicant: Insightec, Ltd.
Product code: Code PLP
Advisory panel: Gastroenterology, Urology
Date received: 2023-05-12
Decision date: 2023-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat-Hacarmet, IL

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