HDI 5000 Ultrasound System With Extended Field of View Imaging
510(k) K002003
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002003 | Date13 Jul 2000 | 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- Withdrawn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
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The HDI 5000 Ultrasound System With Extended Field of View Imaging is a diagnostic ultrasound device designed for real-time imaging of internal body structures. It falls under the category of diagnostic ultrasound systems, enabling clinicians to visualize organs, tissues, and blood flow using high-frequency sound waves. The system incorporates extended field-of-view imaging to provide broader anatomical coverage in a single scan, enhancing diagnostic accuracy. Its advanced imaging capabilities support applications in obstetrics, cardiology, and general radiology.
This device is intended for use in clinical settings such as hospitals, diagnostic imaging centers, and outpatient clinics. Supplied as a reusable system, it requires proper maintenance and calibration to ensure reliable performance. The HDI 5000 is not classified as sterile and must be cleaned and disinfected according to established protocols. It has received FDA 510(k) clearance under the product code IYN, indicating compliance with regulatory standards for diagnostic ultrasound systems. No specific MRI safety classification is noted in the available data.
Other devices from Atl Ultrasound, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the HDI 5000 Ultrasound System With Extended Field of View Imaging used for?
This device is designed for real-time imaging of internal body structures using high-frequency sound waves. Its extended field-of-view imaging feature allows clinicians to capture broader anatomical areas in a single scan, improving diagnostic precision. It supports applications in obstetrics, cardiology, and general radiology, making it versatile for various clinical settings like hospitals and diagnostic centers.
Is the HDI 5000 Ultrasound System reusable or single-use?
The HDI 5000 Ultrasound System is a reusable device. It is intended for use in clinical environments where proper maintenance, cleaning, and disinfection protocols must be followed to ensure reliable performance and prevent cross-contamination between patients. Reusability requires adherence to manufacturer guidelines for calibration and upkeep.
How is sterility maintained for the HDI 5000 Ultrasound System?
The HDI 5000 Ultrasound System is not classified as sterile. Since it is a reusable device, it must be cleaned and disinfected according to established infection control protocols after each use. Proper maintenance, including regular calibration, is also required to ensure optimal performance and safety in clinical settings.
What regulatory approval does the HDI 5000 Ultrasound System hold?
The HDI 5000 Ultrasound System has received FDA 510(k) clearance under product code IYN. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and complies with regulatory standards for diagnostic ultrasound systems. The clearance was granted by the FDA’s Radiology Advisory Committee.
What types of clinical settings is the HDI 5000 Ultrasound System intended for?
This device is intended for use in clinical settings such as hospitals, diagnostic imaging centers, and outpatient clinics. Its advanced imaging capabilities, including extended field-of-view technology, make it suitable for a range of diagnostic applications where detailed visualization of organs, tissues, and blood flow is required.