FDA.reportPublic FDA data

7290019402558

Primary DI
07290019402558
Brand
7290019402558
Company
INSIGHTEC LTD
Model
4000 Type 1.1
Catalog number
SYS004000-CA
Device description
Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue.
Published
2025-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
POHMr-Guided Focused Ultrasound System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POHMr-Guided Focused Ultrasound SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150038036

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150038036EXABLATEInsightec2016-07-11POH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019402558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019402558072900194025587290019402558

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic hyperthermia systemAn assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity75 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius22 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 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
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
07290019402367EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) NON-CESET001046 EXABLATE NEURO PATIENT TREATMENT KIT 1.5SET0010462023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019402565Exablate Neuro Treatment Accessories KitINSIGHTEC LTDPOH2025-05-01
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 LTDPOH2021-08-10
07290015461924INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SETINSIGHTEC LTDPOH2021-08-10
07290015461931HEAD FRAME SET FOR TYPE 1.0 SYSTEMS (R20)INSIGHTEC LTDPOH2021-08-10
07290015461948HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20)INSIGHTEC LTDPOH2021-08-10
07290015461535NEURO V2 1.5T SI COIL PATIENT ACCESSORIES SETINSIGHTEC LTDPOH2020-04-30