111 results
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76ms
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Sources: EU EUDAMED, US FDA
InSightec Ltd.
Manufacturer
🇮🇱 Israel·4 Importers
Exablate Prostate System
FDA registration
INSIGHTEC, LTD.·1 product·🇮🇱 Israel
Exablate Prostate System
FDA registration
INSIGHTEC, LTD.·1 product·🇮🇱 Israel
Exablate Neuro
FDA registration
INSIGHTEC, LTD.·1 product·🇮🇱 Israel
P110039
FDA registration
INSIGHTEC, LTD.·1 product·🇮🇱 Israel
ExAblate
FDA registration
INSIGHTEC, LTD.·2 products·🇮🇱 Israel
Ultrasound, Hyperthermia, Cancer Treatment
FDA Pre-Market Approval
FDA Class 3
·EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET
FDA UDI
INSIGHTEC LTD·07290015461924·INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET. mult...
Low Height Head Frame Set NEURO-V2 (Inegra)
FDA UDI
INSIGHTEC LTD·07290015461917·Low Height Head Frame Set NEURO-V2 (Inegra). mu...
Patient accessory kit
FDA UDI
INSIGHTEC LTD·07290015461047·UF/Bone1 clinical applications single use treat...
ExAblate 2100V1 Pelvic RF Coil 1.5T
FDA UDI
INSIGHTEC LTD·07290015461474·ExAblate 2100V1 PHASE ARRAY ASSY Pelvic RF Coil...
neuro cleaning kit for USA
FDA UDI
INSIGHTEC LTD·07290015461160·single use kit for cleaning the product after a...
Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDA
FDA UDI
INSIGHTEC LTD·07290015461870·A Kit for 10 Neuro treatment (Master Treatment...
Neuro V2 Kit 3T for USA
FDA UDI
INSIGHTEC LTD·07290015461511·Kit for single use during a Neuro V2 treatment ...
Neuro Stereotactic Frame Set
FDA UDI
INSIGHTEC LTD·07290015461283·multi use Stereotactic Frame Set for fixing the...
Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA
FDA UDI
INSIGHTEC LTD·07290015461887·A Kit for 10 Neuro treatment (Master Treatment...
Neuro Kit 3T for USA
FDA UDI
INSIGHTEC LTD·07290015461122·Kit for single use during a Neuro treatment gui...
Exablate DQA Phantom Gel
FDA UDI
INSIGHTEC LTD·07290015461214·Tissue mimic phantom gel for DQA for Body appli...
EXABLATE PROSTATE Treatment master kit for V2.2
FDA UDI
INSIGHTEC LTD·07290019402268·Prostate v2.2 single use master kit for 5 treat...
EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU
FDA UDI
INSIGHTEC LTD·07290019402213·EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU...