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Insightec

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2026-03-23
TypeNumberDevice NameCodeDateActions
PMA P150038 MR-guided focused ultrasound systemPOH2026-03-23 View
PMA P110039 Ablation system, high intensity focused ultrasound (HIFU), MR-guidedNRZ2018-08-16 View

Related Clinical Trials

NCT02246374ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's DiseaseCOMPLETEDNCT03028246A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult SubjectsRECRUITINGNCT04002596Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's DiseaseCOMPLETEDNCT04197921Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)RECRUITINGNCT05317858Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain MetsRECRUITINGNCT07764874Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.NOT_YET_RECRUITING
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