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Neuro Kit 1.5T for USA

INSIGHTEC LTD · Model Neuro Kit 1.5T for USA · UDI-DI 07290015461146

POH Prescription

510(k) clearances

261

Adverse events (5 deaths)

Recalls

Facilities

Description

Kit for single use during a Neuro treatment guided under 1.5T MRI guidance. Kit content: Part Description ASC002258-AA BRAIN COIL 1.5T ASSY MPR000444 HEAD RING SCREWS LONG SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000933 EXABLATE NEURO CLEANING KIT SET400187 NEURO TREATMENT ACCESSORIES KIT

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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.