Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided

Product Code: NRZ

Therapeutic Ultrasonic Devices (Certified)

Definition: An Mr-guided Focused Ultrasound System Is Intended To Use Hifu To Ablate Soft Tissue. Mr Imaging And Thermal Mapping Are Used To Plan And Monitor The Use Of Ultrasound Ablation Before And During The Procedure.

Applicable Standards: None

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyProduct
Annual ReportsYes

Products Classified as NRZ

4126Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided

Total Product Life Cycle (TPLC) Devices

4126Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided

FDA Consensus Standards

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided [32415]21 CFR Unclassified 🔎
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided [32395]21 CFR Unclassified 🔎

Pre-market Approvals for NRZ

P110039Exablate 2100/2100 VI SystemInSightec
P040003Exablate 2100/2100V1 SystemINSIGHTEC, LTD

Global Unique Device Identification Database

07290015461504Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
07290015461498Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
07290015461481Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
07290015461474Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
07290015461467Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
07290015461450Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
07290015461054Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

Maude Adverse Events

HIFU ULTRASOUND MACHINE WITH AN ARRAY TRANSDUCERUNK2019-01-10
EXABLATE 2100INSIGHTEC, LTD.2017-09-27
EXABLATE MRGFUSINSIGHTEC, LTD.2017-08-29
MRGFUS EXABLATEINSIGHTEC LTD.2015-01-23
MRGFUS EXABLATEINSIGHTEC, LTD.2014-09-24
MRGFUS EXABLATEINSIGHTEC LTD.2014-08-13
MRGFUS EXABLATEINSIGHTEC LTD.2014-06-04
EXABLATE 2100INSIGHTEC, LTD.2013-10-02
MRGFUS EXABLATEINSIGHTEC LTD2013-09-05
EXABLATE 2000INSIGHTEC, LTD.2011-05-31
MRGFUS EXABLATEINSIGHTEC LTD.2011-05-22
EXABLATE 2000INSIGHTEC, LTD.2009-11-29
EXABLATE 2000INSIGHTEC, LTD.2008-08-14
EXABLATE 2000INSIGHTEC-TXSONICS, LTD.2008-02-19
SONOLATE-500FOCUS SURGERY, INC.2004-09-14

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