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Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided — Insightec, Ltd. (PMA P040003)

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided — Insightec, Ltd. (PMA P040003) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided; Applicant: Insightec, Ltd.; Clearance track: PMA.

Device nameAblation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
ApplicantInsightec, Ltd.
Clearance trackPMA
Submission numberP040003
DecisionAPPR
Decision date2007-02-27
Date received2006-07-17
Product codeNRZ
Device class3
Medical specialtyUnknown
Applicant locationTX
SourceopenFDA device

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