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EXABLATE NEURO V2

INSIGHTEC LTD · Model SYS0004000-BA 4000 Type 1.1 · UDI-DI 07290015461092

POH Prescription
0
510(k) clearances
261
Adverse events (5 deaths)
0
Recalls
4
Facilities

Description

System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS) for Siemens MRI scanners.

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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.