EXABLATE NEURO V2 EXABLATE 4000 Type 1.1

GUDID 07290015461092

System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS) for Siemens MRI scanners.

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07290015461092
• NIH Device Record Key: d65d38ba-3dc8-47e2-b184-e255751f57cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXABLATE NEURO V2
• Version Model Number: SYS0004000-BA 4000 Type 1.1
• Catalog Number: EXABLATE 4000 Type 1.1
• Company DUNS: 532169513
• Company Name: INSIGHTEC LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com
• Phone: 18663922528
• Email: info@insightec.com

Device Dimensions

• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram
• Weight: 1700 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015461092 [Primary]

FDA Product Code

• POH: Mr-Guided Focused Ultrasound System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-12-13

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