Multi-Dop S

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K926363 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Multi-Dop S used for in clinical settings?

  The Multi-Dop S is designed for radiology applications, utilizing pulsed-echo ultrasound technology to visualize internal body structures in real time. It supports diagnostic evaluations in vascular studies, obstetrics, and general soft-tissue assessments, including blood flow analysis and tissue characterization. Its functionality extends traditional Doppler ultrasound principles, enabling clinicians to assess dynamic physiological processes.

• How is the Multi-Dop S supplied and what are its infection control requirements?

  The Multi-Dop S is supplied as a reusable medical imaging system, intended for use in radiology departments or clinical settings equipped for ultrasound procedures. Since it is not single-use, standard infection control protocols for reusable medical equipment must be followed to ensure patient safety. These protocols typically include cleaning, disinfection, and sterilization procedures as dictated by facility guidelines and regulatory standards.

• Is the Multi-Dop S classified under a specific regulatory category, and what does that mean?

  Yes, the Multi-Dop S is classified under FDA product code IYO, which falls under the Class II regulatory category for imaging systems. This classification means it is subject to performance standards and regulatory oversight to ensure its safety and effectiveness. The device was cleared under FDA 510(k) (K926363) in 1995 as Substantially Equivalent (SESE) to a predicate device, adhering to established safety and performance criteria for pulsed-echo ultrasound systems.

• What types of evaluations can the Multi-Dop S support in clinical practice?

  The Multi-Dop S supports a range of diagnostic evaluations, including vascular assessments (such as blood flow analysis), obstetric imaging (e.g., fetal monitoring), and general soft-tissue evaluations. Its real-time imaging capabilities allow clinicians to visualize and analyze internal structures dynamically, making it versatile for various radiology applications where ultrasound technology is beneficial.

• What was the regulatory pathway for the Multi-Dop S, and when was it cleared?

  The Multi-Dop S underwent a traditional FDA 510(k) review process, submitted to the Radiology (RA) Advisory Committee in 1992. It was cleared on June 19, 1995, under the decision code SESE (Substantially Equivalent to a predicate device). This pathway confirms that the device meets the regulatory standards for Class II imaging systems, ensuring its safety and performance align with existing, cleared technologies.