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Insightec, Ltd.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest Approval2023-10-30
TypeNumberDevice NameCodeDate
510(k) K231378 Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 PLP 2023-10-30 View
PMA P040003 Ablation system, high intensity focused ultrasound (HIFU), MR-guided NRZ 2016-10-28 View
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