Diagnostic Ultrasound System

GUDID 06944413816930

Edan Instruments, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 06944413816930
• NIH Device Record Key: 015f4975-db30-4164-ad30-a417dad47a8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostic Ultrasound System
• Version Model Number: Acclarix AX75
• Company DUNS: 529173163
• Company Name: Edan Instruments, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413816930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250214

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: 2025-04-02
• Device Publish Date: 2025-03-25

On-Brand Devices [Diagnostic Ultrasound System]

• 06944413810723: U60
• 06944413808867: Acclarix AX4
• 06944413807037: P10
• 06944413807020: DUS-5000
• 06944413802575: Acclarix LX8
• 06944413802544: Acclarix LX7
• 06944413802315: Acclarix AX7
• 06944413802285: Acclarix AX8
• 06944413801721: U2
• 06944413801714: U50
• 06944413811584: Acclarix AX18
• 06944413811560: Acclarix AX15
• 06944413811546: Acclarix AX28
• 06944413811522: Acclarix AX25
• 06944413811508: Acclarix AX2 Exp
• 06944413811492: Acclarix AX2 Super
• 06944413811485: Acclarix AX2
• 06944413811478: Acclarix AX3 Exp
• 06944413811461: Acclarix AX3 Super
• 06944413811454: Acclarix AX3
• 06944413813342: Acclarix LX28
• 06944413813328: Acclarix LX25
• 06944413813311: Acclarix LX3 Exp
• 06944413813304: Acclarix LX3 Super
• 06944413813298: Acclarix LX3
• 06944413817036: Acclarix AX88
• 06944413817012: Acclarix AX85
• 06944413817005: Acclarix AX9 Super
• 06944413816992: Acclarix AX9 Exp
• 06944413816985: Acclarix AX9
• 06944413816978: Acclarix AX9 Basic
• 06944413816954: Acclarix AX78
• 06944413816930: Acclarix AX75
• 06944413802308: Acclarix AX8 Super
• 06944413802292: Acclarix AX8 Exp