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

Name: FDA 510(k) clearance K231378
Creator: U.S. Food and Drug Administration
Published: 2023-10-30

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.. Device class: 2.

Clearance details

Applicant: Insightec, Ltd.
Product code: Code PLP
Device class: Class 2
Regulation: 21 CFR 876.4340
Advisory panel: Gastroenterology, Urology
Date received: 2023-05-12
Decision date: 2023-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat-Hacarmet, IL

Download summary PDF View on FDA.gov ↗

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