VistaScan™ 99-7903

GUDID 00850017464025

USB ultrasound probe, general purpose/abdominal

EMAGINE SOLUTIONS TECHNOLOGY LLC

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00850017464025
• NIH Device Record Key: 425ac7d8-9257-4172-a874-a49029765e69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaScan™
• Version Model Number: GP-C01
• Catalog Number: 99-7903
• 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: 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: +1 (888) 345-1115
• Email: info@emaginesolutionstech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017464025 [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