FDA.reportPublic FDA data

Neuro Stereotactic Frame Set

Primary DI
07290015461283
Brand
Neuro Stereotactic Frame Set
Company
INSIGHTEC LTD
Model
Neuro Stereotactic Frame Set
Catalog number
SET400168
Device description
multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
Published
2017-07-31
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
POHMr-Guided Focused Ultrasound System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSYUltrasound, Hyperthermia, Cancer TreatmentUnknown3
POHMr-Guided Focused Ultrasound SystemUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015461283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015461283072900154612837290015461283

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 Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

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
Sterilization required before use
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
07290019402565Exablate Neuro Treatment Accessories KitINSIGHTEC LTDPOH2025-05-01
072900194025587290019402558INSIGHTEC LTDPOH2025-01-01
07290019402442HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)INSIGHTEC LTDPOH2023-06-26
07290019402466HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)INSIGHTEC LTDPOH2023-06-26
07290019402305EX NEURO PATIENT TREATMENT KIT 3.0T WO COIL (5) NON-CEINSIGHTEC LTDPOH2023-02-15
07290019402329EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CEINSIGHTEC LTDPOH2023-02-15
07290019402343EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CEINSIGHTEC LTDPOH2023-02-15
07290019402367EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) NON-CEINSIGHTEC LTDPOH2023-02-15
07290019402381EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CEINSIGHTEC LTDPOH2023-02-15
07290019402121EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SIINSIGHTEC LTDPOH2022-12-15
07290019402138EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SUINSIGHTEC LTDPOH2022-12-15
07290019402145EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GEINSIGHTEC LTDPOH2022-12-15
07290019402152EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SUINSIGHTEC LTDPOH2022-12-15
07290019402169EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GEINSIGHTEC LTDPOH2022-12-15
07290019402176EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SUINSIGHTEC LTDPOH2022-12-15
07290019402183EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SIINSIGHTEC LTDPOH2022-12-15
07290019402190EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SUINSIGHTEC LTDPOH2022-12-15
07290019402206EX NEURO PATIENT TREATMENT KIT 3.0T WO COILINSIGHTEC LTDPOH2022-12-15
07290019402213EX NEURO PATIENT TREATMENT KIT 3.0T WO COIL SUINSIGHTEC LTDPOH2022-12-15
07290019402220Head Frame Set for Type 1.0 Systems FDA/ROWINSIGHTEC LTDPOH2022-12-15
07290019402237Head Frame Set for Type 1.1 Systems FDA/ROWINSIGHTEC LTDPOH2022-12-15
07290015461863Master Treatment Kit for 3.0T wo Headcoil, Type 1.0& 1.1 NonCE/FDAINSIGHTEC LTDPOH2021-08-10
07290015461870Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDAINSIGHTEC LTDPOH2021-08-10
07290015461887Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDAINSIGHTEC LTDPOH2021-08-10
07290015461894Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDAINSIGHTEC LTDPOH2021-08-10
07290015461900Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDAINSIGHTEC LTDPOH2021-08-10
07290015461917Low Height Head Frame Set NEURO-V2 (Inegra)INSIGHTEC LTDLSY2021-08-10
07290015461917Low Height Head Frame Set NEURO-V2 (Inegra)INSIGHTEC LTDPOH2021-08-10
07290015461924INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SETINSIGHTEC LTDLSY2021-08-10
07290015461924INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SETINSIGHTEC LTDPOH2021-08-10