VistaScan™

GUDID 00850017464001

VistaScan™ Software 1.x.x

EMAGINE SOLUTIONS TECHNOLOGY LLC

Ultrasound imaging system application software

• Primary Device ID: 00850017464001
• NIH Device Record Key: 5b006509-8ffc-4f7e-9c8d-f5400537862f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaScan™
• Version Model Number: 1.x.x
• Company DUNS: 080648419
• Company Name: EMAGINE SOLUTIONS TECHNOLOGY LLC
• 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: 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: +1 (888) 345-1115
• Email: info@emaginesolutionstech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017464001 [Primary]

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [VistaScan™]

• 00850017464032: USB ultrasound probe, small parts
• 00850017464025: USB ultrasound probe, general purpose/abdominal
• 00850017464018: USB ultrasound probe, general purpose/abdominal
• 00850017464001: VistaScan™ Software 1.x.x