SuperSonic HepaVu ASY-HEPA-INTL

GUDID 03760193600384

SuperSonic HepaVu

Supersonic Imagine, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 03760193600384
• NIH Device Record Key: 06a05e4d-4580-4d6b-8285-7f672675a49c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperSonic HepaVu
• Version Model Number: ASY-HEPA-INTL
• Catalog Number: ASY-HEPA-INTL
• Company DUNS: 034094134
• Company Name: Supersonic Imagine, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com
• Phone: +33(0)442992424
• Email: contactsFR@supersonicimagine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760193600384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242223

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: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by Supersonic Imagine, Inc.

• 03760193600384 - SuperSonic HepaVu: 2025-03-18SuperSonic HepaVu
• 03760193600384 - SuperSonic HepaVu: 2025-03-18 SuperSonic HepaVu
• 03760193600223 - LV16-5 Transducer: 2023-03-01
• 03760193600230 - SUPERSONIC MACH 20: 2023-03-01
• 03760193600254 - SUPERSONIC MACH 30: 2023-03-01
• 03760193600308 - AIXPLORER MACH 20 - 220V SYSTEM: 2023-03-01
• 03760193600001 - SL15-4 Gen I®: 2023-02-28 Linear Probe SL15-4 Gen I®
• 03760193600018 - Aixplorer®: 2023-02-28 Imaging Ultrasound Diagnostic System
• 03760193600025 - SL15-4 Gen II®: 2023-02-28 Linear Probe SL15-4 Gen II®