U Lite

GUDID 37011046002914

Handheld Ultrasound Scanner U Lite Pro with exchangeables probes

SONOSCANNER

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

• Primary Device ID: 37011046002914
• NIH Device Record Key: 2712c9fd-a7bd-4620-8d76-9f3b4e9ec7a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U Lite
• Version Model Number: PRO
• Company DUNS: 267799927
• Company Name: SONOSCANNER
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	37011046002914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232285

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, 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: 2024-01-24
• Device Publish Date: 2024-01-16

Devices Manufactured by SONOSCANNER

• 37011046002914 - U Lite: 2024-01-24Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
• 37011046002914 - U Lite: 2024-01-24 Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
• 03701104600116 - T-Lite: 2020-11-30 Handheld Ultrasound Scanner T-Lite with exchangeable probes
• 03701104600123 - T-Lite: 2020-11-30 Convex Access probe 2-5Mhz
• 03701104600130 - T-Lite: 2020-11-30 Linear Access Probe 5-12.5 Mhz
• 03701104600147 - T-Lite: 2020-11-30 MicroConvex Probe R15 4-9Mhz
• 03701104600154 - T-Lite: 2020-11-30 Single Crystal Convex Probe 1.5-6Mhz
• 03701104600161 - T-Lite: 2020-11-30 Hockey Stick Probe 10-18Mhz