ADVANCED ULTRASOUND

GUDID B510DUS5000A1

ADVANCED INSTRUMENTATIONS, INC.

General-purpose ultrasound imaging system

• Primary Device ID: B510DUS5000A1
• NIH Device Record Key: dd33313d-858b-41b6-aa6f-a7141aa8a765
• Commercial Distribution Discontinuation: 2028-04-15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED ULTRASOUND
• Version Model Number: DUS-5000
• Company DUNS: 608736880
• Company Name: ADVANCED INSTRUMENTATIONS, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B510DUS5000A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132059

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2020-04-27
• Device Publish Date: 2020-04-17

On-Brand Devices [ADVANCED ULTRASOUND]

• B510DUS5000A1: DUS-5000
• B510DUS30001: DUS-3000