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Insightec, Ltd.

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

Total Devices2
Categories2
Latest FDA decision2025-07-23
TypeNumberDevice NameCodeDateActions
PMA P040003 Ablation system, high intensity focused ultrasound (HIFU), MR-guidedNRZ2025-07-23 View
510(k) K231378 Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0PLP2023-10-30 View

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