Digital Ultrasonic Diagnostic Imaging System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

General-purpose ultrasound imaging system

Model / Reference

DUS 60

Primary DI / UDI-DI

06944413800830

Basic UDI-DI

69444138DUS60RA

510(k) Number

K110999 ↗ 510(k)

K131830 ↗ GUDID

FDA Product Code

ITX, IYO

EMDN Code

Z11040101 Internal ultrasound scanners

GMDN Term

General-purpose ultrasound imaging system

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.1570 510(k)GUDID

892.1560 GUDID

EU market of registration

Germany

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• SpO2 sensor

  Class IIb

  CE/MDR

• NIBP Cuff

  Class I

  CE/MDR

• Temperature Probe

  Class IIb

  CE/MDR

• Biofeedback and Stimulation System

  Class IIa

  CE/MDR

• Ultrasonic Pocket Doppler

  Class IIa

  CE/MDR

• ECG Cable

  Class I

  CE/MDR

See all devices from Edan Instruments, Inc. →

• What types of clinical settings is this ultrasound system designed for, and how does its portability factor into its use?

  The DUS60 is engineered for clinical, mobile, and point-of-care environments, making it versatile for hospitals, emergency departments, and even remote or field settings. Its durable construction and design emphasize ease of transport, allowing clinicians to perform diagnostic imaging where traditional stationary systems may not be practical. The system’s adaptability supports real-time evaluations of organs, tissues, and blood flow via Doppler imaging, ensuring flexibility in patient care scenarios.

• How is the DUS60 sterilized between uses, and what precautions should be taken during its reuse?

  The DUS60 is a reusable device, so it must undergo appropriate sterilization protocols between patient uses to ensure safety and hygiene. The manufacturer recommends following standard medical imaging equipment sterilization guidelines, which typically include high-level disinfection or sterilization methods like autoclaving or chemical sterilization, depending on the manufacturer’s instructions. Proper cleaning and sterilization are critical to prevent cross-contamination and maintain device integrity.

• Is this ultrasound system compatible with MRI environments, and if not, what safety considerations should be noted?

  The DUS60 does not have a specified MRI safety classification in the provided data, meaning its compatibility with MRI environments (e.g., proximity to MRI machines or use in MRI suites) is not confirmed or documented. Clinicians should assume it may not be MRI-safe unless explicitly verified by the manufacturer. If used near MRI equipment, extra caution is advised to avoid interference or safety risks, such as ferromagnetic components affecting imaging or patient safety.

• What regulatory pathways does this device follow, and how does its classification impact its use?

  The DUS60 follows FDA 510(k) clearance (K110999) under the Radiology (RA) advisory committee, with a decision of Substantially Equivalent (SESE) to a predicate device. It also complies with MDR (Medical Device Regulation) standards. This classification means the device has undergone rigorous review by the FDA’s Radiology panel to ensure safety and effectiveness for its intended diagnostic purposes, such as imaging organs, tissues, and blood flow. The ITX product code further categorizes it under ultrasound imaging devices, reinforcing its regulatory alignment with diagnostic imaging standards.