Vscan

GUDID 00195278640567

Vscan Air R2 for Android

GE Vingmed Ultrasound AS

Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software

• Primary Device ID: 00195278640567
• NIH Device Record Key: 4279f24a-5ac0-4ba0-977c-9c74b530ad75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vscan
• Version Model Number: Air R2 for Android
• Company DUNS: 518870571
• Company Name: GE Vingmed Ultrasound AS
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00195278640567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231301

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: 2023-10-04
• Device Publish Date: 2023-09-26

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• 00840682107891: Dual Probe
• 00840682107853: v1.2
• 00840682147484: Vscan Air CL A1
• 00840682147101: Vscan Air for Android
• 00840682147071: Vscan Air for iOS
• 00195278660701: Vscan Air SL
• 00195278640574: Vscan Air R2 Upgrade kit
• 00195278640567: Vscan Air R2 for Android
• 00195278640550: Vscan Air R2 for iOS