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7290019402558

INSIGHTEC LTD · Model 4000 Type 1.1 · UDI-DI 07290019402558

POH Prescription

510(k) clearances

261

Adverse events (5 deaths)

Recalls

Facilities

Description

Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.