Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.
INSIGHTEC LTD
2100 Type 1.0/1.1/1.11
In Commercial Distribution

  • 07290015461016 ()

  • Weight: 890 Kilogram
EXABLATE 2100

  • Therapeutic oncological/gynaecological ultrasound system
System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS).
INSIGHTEC LTD
2000
In Commercial Distribution

  • 07290015461009 ()

  • Weight: 890 Kilogram
EXABLATE 2000

  • Therapeutic oncological/gynaecological ultrasound system
HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK
INSIGHTEC LTD
SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)
In Commercial Distribution

  • 07290019402466 ()
SET400168-AE

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE
In Commercial Distribution

  • 07290019402381 ()
SET001047

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE
In Commercial Distribution

  • 07290019402343 ()
SET001045

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001044 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE
In Commercial Distribution

  • 07290019402329 ()
SET001044

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 4000 (Neuro) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE
In Commercial Distribution

  • 07290019402305 ()
SET001043

  • Therapeutic oncological/gynaecological ultrasound system
INSIGHTEC-MADE Head Frame Set for Type 1.1 Systems FDA/ROW. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-BD Head Frame Set for Type 1.1 Systems FDA/ROW
In Commercial Distribution

  • 07290019402237 ()
SET400168-BD

  • Therapeutic oncological/gynaecological ultrasound system
INSIGHTEC-MADE Head Frame Set for Type 1.0 Systems FDA/ROW. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-BC Head Frame Set for Type 1.0 Systems FDA/ROW
In Commercial Distribution

  • 07290019402220 ()
SET400168-BC

  • Therapeutic oncological/gynaecological ultrasound system
EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU w/PFK for 1 treatment PFK package served ETO-sterile
INSIGHTEC LTD
SET001117-SU (w/ PFK) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU
In Commercial Distribution

  • 07290019402213 ()
SET001117-SU

  • Therapeutic oncological/gynaecological ultrasound system
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