SonoVision

GUDID 00860001239355

SonoVision Ultrasound Imaging Console

Tissue Differentiation Intelligence LLC

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 00860001239355
• NIH Device Record Key: 8559d880-b8cb-4a64-bce8-232065341687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoVision
• Version Model Number: 100009
• Company DUNS: 081327336
• Company Name: Tissue Differentiation Intelligence LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com
• Phone: 305-351-2011
• Email: customerservice@tissueintel.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 101 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *This End Up

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001239355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192388

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-11
• Device Publish Date: 2022-03-03

On-Brand Devices [SonoVision]

• 00860001239355: SonoVision Ultrasound Imaging Console
• 00860001239300: SonoVision Accessory Kit