FDA.reportPublic FDA data

EXABLATE

Primary DI
07290015461016
Brand
EXABLATE
Company
INSIGHTEC LTD
Model
2100 Type 1.0/1.1/1.11
Catalog number
EXABLATE 2100
Device description
System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSYUltrasound,Hyperthermia, Cancer Treatment
NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSYUltrasound, Hyperthermia, Cancer TreatmentUnknown3
NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-GuidedUnknown3
PLPHigh Intensity Ultrasound System For Prostate Tissue AblationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015461016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015461016072900154610167290015461016

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic oncological/gynaecological ultrasound systemAn assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. It typically consists of a piezoelectric transducer (probe), a water supply/power control unit, operator console and monitoring systems, software, and sometimes a patient table. Optimal patient positioning is achieved using an ultrasound scanner or MRI system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight890Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18663922528info@insightec.com

Regulatory Flags#

DUNS number
532169513
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019402565Exablate Neuro Treatment Accessories KitExablate 4000 SET004307-ROW2025-05-01
0729001940255872900194025584000 Type 1.1SYS004000-CA 2025-01-01
07290019402442HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)SET400168-AD PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)SET400168-AD2023-06-26
07290019402466HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)SET400168-AE2023-06-26
07290019402121EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SISET001113 (w/ PFK) EXABLATE NEURO PATIENT TREATMENSET0011132022-12-15
07290019402138EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SUSET001113-SU (w/ PFK) EXABLATE NEURO PATIENT TREATSET001113-SU2022-12-15
07290019402145EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GESET001114 (w/ PFK) EXABLATE NEURO PATIENT TREATMENSET0011142022-12-15
07290019402152EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SUSET001114-SU (w/ PFK) EXABLATE NEURO PATIENT TREATSET001114-SU2022-12-15
07290019402169EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GESET001115 (w/ PFK) EXABLATE NEURO PATIENT TREATMENSET0011152022-12-15
07290019402176EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SUSET001115-SU (w/ PFK) EXABLATE NEURO PATIENT TREATSET001115-SU2022-12-15
07290019402183EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SISET001116 (w/ PFK) EXABLATE NEURO PATIENT TREATMENSET0011162022-12-15
07290019402190EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SUSET001116-SU (w/ PFK) EXABLATE NEURO PATIENT TREATSET001116-SU2022-12-15
07290019402206EX NEURO PATIENT TREATMENT KIT 3.0T WO COILSET001117 (w/ PFK) EX NEURO PATIENT TREATMENT KIT SET0011172022-12-15
07290019402213EX NEURO PATIENT TREATMENT KIT 3.0T WO COIL SUSET001117-SU (w/ PFK) EX NEURO PATIENT TREATMENT KSET001117-SU2022-12-15
07290019402220Head Frame Set for Type 1.0 Systems FDA/ROWSET400168-BC Head Frame Set for Type 1.0 Systems FSET400168-BC2022-12-15
07290019402237Head Frame Set for Type 1.1 Systems FDA/ROWSET400168-BD Head Frame Set for Type 1.1 Systems FSET400168-BD2022-12-15
07290019402268EXABLATE PROSTATE Treatment master kit for V2.2PROSTATE WATERLESS MASTER KIT FOR 5 TREATMENTS (FDSET0016532022-12-15
07290019402305EX NEURO PATIENT TREATMENT KIT 3.0T WO COIL (5) NON-CESET001043 EX NEURO PATIENT TREATMENT KIT 3.0T WO CSET0010432023-02-15
07290019402329EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CESET001044 EXABLATE NEURO PATIENT TREATMENT KIT 1.5SET0010442023-02-15
07290019402343EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CESET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0SET0010452023-02-15

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Primary DI, Brand, Company table
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