FDA.reportPublic FDA data

ExAblate 2100V1 LOWER PELVIC COIL 1.5T

Primary DI
07290015461450
Brand
ExAblate 2100V1 LOWER PELVIC COIL 1.5T
Company
INSIGHTEC LTD
Model
ASC001361 ExAblate 2100V1 LOWER PELVIC COIL
Catalog number
ASC001361
Device description
ExAblate 2100V1 LOWER PELVIC RF COIL for 1.5T MR guided FUS Body (Uterine fibroids, bone mets) treatments
Published
2018-11-29
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSYUltrasound, Hyperthermia, Cancer TreatmentUnknown3
NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-GuidedUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015461450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015461450072900154614507290015461450

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature-15 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18663922528info@insightec.com

Regulatory Flags#

DUNS number
532169513
Device count
1
DM exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290015461917Low Height Head Frame Set NEURO-V2 (Inegra)INSIGHTEC LTDLSY2021-08-10
07290015461924INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SETINSIGHTEC LTDLSY2021-08-10
07290015461931HEAD FRAME SET FOR TYPE 1.0 SYSTEMS (R20)INSIGHTEC LTDLSY2021-08-10
07290015461948HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20)INSIGHTEC LTDLSY2021-08-10
07290015461405NEURO V2 PATIENT TREAT.KITS 3T MASTER SETINSIGHTEC LTDLSY2018-11-29
07290015461429Neuro V2 Kit 3T for USAINSIGHTEC LTDLSY2018-11-29
07290015461467ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5TINSIGHTEC LTDNRZ2018-11-29
07290015461467ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5TINSIGHTEC LTDLSY2018-11-29
07290015461474ExAblate 2100V1 Pelvic RF Coil 1.5TINSIGHTEC LTDNRZ2018-11-29
07290015461474ExAblate 2100V1 Pelvic RF Coil 1.5TINSIGHTEC LTDLSY2018-11-29
07290015461481ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MRINSIGHTEC LTDNRZ2018-11-29
07290015461481ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MRINSIGHTEC LTDLSY2018-11-29
07290015461498ExAblate 2100 LOWER PELVIC COIL ASSEMBLYINSIGHTEC LTDNRZ2018-11-29
07290015461498ExAblate 2100 LOWER PELVIC COIL ASSEMBLYINSIGHTEC LTDLSY2018-11-29
07290015461504ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COILINSIGHTEC LTDNRZ2018-11-29
07290015461504ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COILINSIGHTEC LTDLSY2018-11-29
07290015461238Neuro Patient Accessory KitINSIGHTEC LTDLSY2017-07-31
07290015461245Neuro Helmet SealantINSIGHTEC LTDLSY2017-07-31
07290015461283Neuro Stereotactic Frame SetINSIGHTEC LTDLSY2017-07-31
07290015461290Neuro Stereotactic FrameINSIGHTEC LTDLSY2017-07-31
07290015461306Neuro Protective Frame Pin CupINSIGHTEC LTDLSY2017-07-31
07290015461313Neuro Stereotactic Frame Screws SetINSIGHTEC LTDLSY2017-07-31
07290015461320Neuro Stereotactic Frame PostsINSIGHTEC LTDLSY2017-07-31
07290015461337Neuro Frame Attachment StrapINSIGHTEC LTDLSY2017-07-31
07290015461160neuro cleaning kit for USAINSIGHTEC LTDLSY2017-06-30
07290015461047Patient accessory kitINSIGHTEC LTDNRZ2017-06-07
07290015461047Patient accessory kitINSIGHTEC LTDLSY2017-06-07
07290015461054water bag kitINSIGHTEC LTDNRZ2017-06-07
07290015461054water bag kitINSIGHTEC LTDLSY2017-06-07
07290015461085Gel Pad ASSYINSIGHTEC LTDLSY2017-06-07