DEVICE: EXABLATE NEURO (07290015461023)
Device Identifier (DI) Information
EXABLATE NEURO
4000 Type 1.0
In Commercial Distribution
EXABLATE 4000 Type 1.0
INSIGHTEC LTD
4000 Type 1.0
In Commercial Distribution
EXABLATE 4000 Type 1.0
INSIGHTEC LTD
System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetiv Resonance (MR) guidance (i.e. MRgFUS).
Device Characteristics
MR Safe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57888 | Therapeutic oncological/gynaecological ultrasound system |
An 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
POH | Mr-Guided Focused Ultrasound System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 60 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 700 and 1060 KiloPascal |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 700 and 1060 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Weight: 1350 Kilogram |
Device Record Status
8a3039a1-fbe3-4100-a149-ea6efa46e4eb
June 22, 2023
5
August 03, 2016
June 22, 2023
5
August 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18663922528
info@insightec.com
info@insightec.com