DEVICE: EXABLATE (07290015461016)
Device Identifier (DI) Information
EXABLATE
2100 Type 1.0/1.1/1.11
In Commercial Distribution
EXABLATE 2100
INSIGHTEC LTD
2100 Type 1.0/1.1/1.11
In Commercial Distribution
EXABLATE 2100
INSIGHTEC LTD
System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.
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 |
---|---|
LSY | Ultrasound,Hyperthermia, Cancer Treatment |
NRZ | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided |
PLP | High Intensity Ultrasound System For Prostate Tissue Ablation |
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: 890 Kilogram |
Device Record Status
cc1379b3-0c41-48cf-8630-4f750fc78f73
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