FDA Device Intelligence
Home › INSIGHTEC LTD › EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU

INSIGHTEC LTD · Model SET001114-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU · UDI-DI 07290019402152

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

Description

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.