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ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MR

INSIGHTEC LTD · Model OPT000037-AR ExAblate 2100V1 Pelvic RF Coil for Body · UDI-DI 07290015461481

NRZ LSY Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

PHASE ARRAY ASSY Pelvic RF Coil for MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASC001361-AR - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1 under Artist MR guidance

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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.