FDA.reportPublic FDA data

Patient accessory kit

Primary DI
07290015461047
Brand
Patient accessory kit
Company
INSIGHTEC LTD
Model
Patient accessory kit for Body
Catalog number
SET000016
Device description
UF/Bone1 clinical applications single use treatment kit
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040003017
P110039005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040003017EXABLATE 2000 SYSTEMInsightec, Ltd.2004-10-22NRZ
P110039005EXABLATEInsightec2012-10-18NRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015461047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015461047072900154610477290015461047

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 Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius25 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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
07290015461450ExAblate 2100V1 LOWER PELVIC COIL 1.5TINSIGHTEC LTDLSY2018-11-29
07290015461450ExAblate 2100V1 LOWER PELVIC COIL 1.5TINSIGHTEC LTDNRZ2018-11-29
07290015461467ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5TINSIGHTEC LTDLSY2018-11-29
07290015461467ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5TINSIGHTEC LTDNRZ2018-11-29
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 LTDLSY2018-11-29
07290015461498ExAblate 2100 LOWER PELVIC COIL ASSEMBLYINSIGHTEC LTDNRZ2018-11-29
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
07290015461054water bag kitINSIGHTEC LTDLSY2017-06-07
07290015461054water bag kitINSIGHTEC LTDNRZ2017-06-07
07290015461085Gel Pad ASSYINSIGHTEC LTDNRZ2017-06-07