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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Intensity Ultrasound System For Prostate Tissue Ablation
510(k) Number K231378
Device Name Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
Applicant
Insightec , Ltd.
5 Nachum Heth St.
Tirat Carmel,  IL 39120
Applicant Contact Inbal Ben Tzvi
Correspondent
Insightec, Inc.
4851 Lbj Freeway, Suite 400
Dallas,  TX  75244
Correspondent Contact Nadir Alikacem
Regulation Number876.4340
Classification Product Code
PLP  
Date Received05/12/2023
Decision Date 10/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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