Vscan

GUDID 00195278640574

Vscan Air R2 Upgrade kit

GE Vingmed Ultrasound AS

Ultrasound imaging system application software

• Primary Device ID: 00195278640574
• NIH Device Record Key: ae56d645-02e8-4616-a1e1-8156df68c133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vscan
• Version Model Number: Air R2 CL
• 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	00195278640574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231301

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

On-Brand Devices [Vscan]

• 00840682121651: Extend
• 00840682115384: Gateway v.1.4
• 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