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EXABLATE

INSIGHTEC LTD · Model 2100 Type 1.0/1.1/1.11 · UDI-DI 07290015461016

LSYNRZPLP Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
1
Facilities

Description

System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.

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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.