111 results · 68ms · Sources: EU EUDAMED, US FDA

Head Frame Set for Type 1.0 Systems FDA/ROW

FDA UDI
INSIGHTEC LTD·07290019402220·INSIGHTEC-MADE Head Frame Set for Type 1.0 Syst...

Neuro Stereotactic Frame

FDA UDI
INSIGHTEC LTD·07290015461290·a multi use ASM001399 for fixing the skull pos...

Gel Pad ASSY

FDA UDI
INSIGHTEC LTD·07290015461085·Transmission gel pad for single Body treatment....

ExAblate 2100 LOWER PELVIC COIL ASSEMBLY

FDA UDI
INSIGHTEC LTD·07290015461498·ExAblate 2100 LOWER PELVIC COIL ASSEMBLY for MR...

ExAblate 2100V1 LOWER PELVIC COIL 1.5T

FDA UDI
INSIGHTEC LTD·07290015461450·ExAblate 2100V1 LOWER PELVIC RF COIL for 1.5T M...

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE 2000 SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·InSightec ExAblate System

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE 2000, VERSION 4.22

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE 2000 SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE 2000/2100

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·Exablate 2100/2100V1 System

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE 2000 SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE 2000

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE DEVICE

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE