Eup-C321 5.0MHZ Convex Type Probe

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

510(k) Number

K890532 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What types of medical examinations is the EUP-C321 5.0 MHz Convex Type Probe primarily designed for, and why?

  The EUP-C321 is specifically designed for abdominal, obstetric, and small-part examinations. Its convex shape provides a broad field of view and deeper penetration, making it ideal for imaging larger organs and structures like the liver, kidneys, or uterus, as well as smaller areas like thyroid or superficial lymph nodes.

• Is the EUP-C321 probe single-use or reusable, and what maintenance does it require?

  The EUP-C321 is a reusable probe, meaning it is intended for repeated use across multiple patients after proper cleaning and maintenance. Since it is reusable, it must be cleaned and disinfected according to the manufacturer’s guidelines to prevent contamination and ensure reliable performance over time.

• Which Hitachi Aloka ultrasound systems is this probe compatible with, and how does that affect its use?

  The EUP-C321 is designed to work exclusively with Hitachi Aloka ultrasound systems, including the EUB-405 and Spazio Plus. This compatibility ensures seamless integration and optimal imaging performance, as the probe’s specifications are tailored to these specific systems.

• How was the regulatory approval process for this probe handled, and what does that mean for its use?

  The EUP-C321 received FDA clearance through a 510(k) submission, classified under the Radiology advisory committee (RA) and determined to be substantially equivalent to a predicate device. This means the probe was reviewed for safety and effectiveness compared to an existing approved ultrasound probe, ensuring it meets regulatory standards for diagnostic imaging use.