Mr-guided Focused Ultrasound System

Product Code: POH

Ultrasonic Medical Devices (Miscellaneous)

Definition: An Mr-guided Focused Ultrasound System Is Intended To Use High Intensity Focused Ultrasound (hifu) To Heat And Ablate Soft Tissue In The Brain To Treat Neurological Disorders. Mr Imaging And Thermal Mapping Are Used To Plan And Monitor The Use Of The Device During The Procedure.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyProduct
Annual ReportsNo

Products Classified as POH

3867Mr-guided Focused Ultrasound System

Total Product Life Cycle (TPLC) Devices

3867Mr-guided Focused Ultrasound System

Pre-market Approvals for POH

P150038Exablate 4000 SystemInSightec

Global Unique Device Identification Database

07290015461443Mr-Guided Focused Ultrasound System
07290015461399Mr-Guided Focused Ultrasound System
07290015461382Mr-Guided Focused Ultrasound System
07290015461375Mr-Guided Focused Ultrasound System
07290015461368Mr-Guided Focused Ultrasound System
07290015461351Mr-Guided Focused Ultrasound System
07290015461344Mr-Guided Focused Ultrasound System
07290015461092Mr-Guided Focused Ultrasound System
07290015461528Mr-Guided Focused Ultrasound System
07290015461511Mr-Guided Focused Ultrasound System
07290015461566Mr-Guided Focused Ultrasound System
07290015461559Mr-Guided Focused Ultrasound System
07290015461542Mr-Guided Focused Ultrasound System
07290015461535Mr-Guided Focused Ultrasound System
07290015461900Mr-Guided Focused Ultrasound System

Maude Adverse Events

EXABLATE 4000INSIGHTEC LTD2020-03-24
EXABLATE 4000INSIGHTEC2020-03-18
EXABLATE 4000INSIGHTEC LTD2020-03-12
EXABLATE 4000INSIGHTEC LTD2020-03-04
EXABLATE 4000INSIGHTEC LTD2020-03-04
EXABLATE 4000INSIGHTEC LTD2020-02-26
EXABLATE 4000INSIGHTEC LTD2020-01-28
EXABLATE 4000INSIGHTEC2019-11-20
EXABLATE 4000INSIGHTEC2019-11-13
EXABLATE 4000INSIGHTEC2019-11-07
EXABLATE 4000INSIGHTEC2019-10-17
EXABLATE 4000INSIGHTEC2019-09-12
EXABLATE 4000INSIGHTEC2019-07-23
EXABLATE 4000INSIGHTEC2019-07-23
EXABLATE 4000INSIGHTEC2019-07-23
EXABLATE 4000INSIGHTEC2019-06-25
EXABLATE 4000INSIGHTEC2019-06-25
EXABLATE 4000INSIGHTEC2019-05-23
EXABLATE 4000INSIGHTEC2019-05-23
EXABLATE 4000INSIGHTEC LTD2019-05-05
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 2100INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABALTE 4000INSIGHTEC LTD2019-04-24
EXABLATE 4000INSIGHTEC LTD2019-04-08
EXABALTE 4000INSIGHTEC LTD2018-09-06
EXABLATE NEUROINSIGHTEC HAIFA ISRAEL, INSIGHTEC, LTD.2018-05-02
FOCUSED MAGNETIC ULTRASOUND FOR CENTRAL TREMORSINSIGHTEC, LTD.2018-03-09
EXABLATE NEUROINSIGHTEC, LTD.2017-12-08
EXABLATE NEUROINSIGHTEC, LTD.2017-12-07
EXABLATE 4000INSIGHTEC, LTD.2017-10-10
EXABLATE 4000INSIGHTEC, LTD.2017-08-29
EXABLATE 2100INSIGHTEC, LTD2017-08-29
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