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510(k) K231378

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 by Insightec , Ltd. — Product Code PLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2023
Date Received
May 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class
Class II
Regulation Number
876.4340
Review Panel
GU
Submission Type

Prostate tissue ablation

Other clearances by Insightec , Ltd.

  • K212150 — Exablate Prostate System (November 23, 2021)

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  • K172721 — FOCAL ONE (June 7, 2018)
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