EUB-555A+
by Hitachi Medical Corp. of America
510(k) K945795
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945795 | Date27 Oct 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The EUB-555A+ is an ultrasound imaging system classified under the Diagnostic Ultrasound device type, designed for radiologic examination. It generates real-time visual images of internal body structures using high-frequency sound waves, aiding in the diagnosis of various conditions such as organ function, tissue abnormalities, and vascular health. This device operates within the radiology setting, providing clinicians with critical diagnostic information for patient care.
The EUB-555A+ is supplied as a reusable medical device and is intended for use in clinical radiology departments. It holds an FDA 510(k) clearance under the Substantially Equivalent determination, classified as a Class II device (product code IYO). No specific sterility requirements are noted, but standard hospital infection control protocols should be followed. The device’s regulatory status is confirmed through the Radiology (RA) Advisory Committee review process, with no additional MRI safety or size-specific constraints mentioned in the available data.
Other devices from Hitachi Medical Corp. of America
Questions
AI-generated answers, 1 Oct 2026
What is the EUB-555A+ used for in clinical practice?
The EUB-555A+ is a diagnostic ultrasound system designed for radiologic examinations. It generates real-time images of internal body structures using high-frequency sound waves, helping clinicians assess organ function, identify tissue abnormalities, and evaluate vascular health. This aids in diagnosing conditions such as tumors, cysts, or cardiovascular issues, making it essential for patient care in radiology departments.
Is the EUB-555A+ a single-use or reusable device?
The EUB-555A+ is supplied as a reusable medical device. While it is not sterile out-of-the-box, it is intended for repeated use in clinical radiology settings. Standard hospital infection control protocols must be followed to ensure safe reuse, including proper cleaning and maintenance between patient examinations.
What regulatory approval does the EUB-555A+ hold?
The EUB-555A+ holds FDA 510(k) clearance under the Substantially Equivalent determination, classified as a Class II device with product code IYO. This means it has been reviewed by the FDA’s Radiology (RA) Advisory Committee and deemed equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for diagnostic ultrasound imaging.
Does the EUB-555A+ have any special storage or handling requirements?
While no specific sterility requirements are noted for the EUB-555A+, it is a reusable device intended for clinical radiology use. Proper storage involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for maintenance, calibration, and routine cleaning to preserve functionality and ensure compliance with hospital infection control protocols.
What type of advisory committee reviewed the EUB-555A+ during its FDA submission?
The EUB-555A+ was reviewed by the FDA’s Radiology (RA) Advisory Committee as part of its 510(k) clearance process. This committee provides expert input on diagnostic radiology devices, ensuring the device meets safety and performance standards for ultrasound imaging in clinical settings.