HI Vision Ascendus
by Hitachi Aloka Medical America, Inc.
510(k) K153421
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153421 | Date21 Jan 2016 | 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- Withdrawn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
- Full name
- Hi Vision Ascendus, Hv Ascendus, Ascendus
- 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, 19 Sep 2026
The HI Vision Ascendus is a diagnostic ultrasound system (Product Code IYN), designed to emit ultrasound energy via transducers and capture reflected echoes from tissues to generate real-time imaging for clinical assessment. It is classified under the Radiology advisory committee category and operates as a Class II device under FDA regulations.
This system is intended for use in clinical settings by trained clinicians, including physicians and sonographers, and is supplied as a reusable medical device. It requires proper storage and maintenance in accordance with manufacturer guidelines, though no specific sterility or MRI safety information is provided in the available data. The device holds an FDA 510(k) clearance (K153421) with a decision of Substantially Equivalent, as determined by the Radiology panel.
Other devices from Hitachi Aloka Medical America, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings or specialties would benefit most from using the HI Vision Ascendus ultrasound system?
The HI Vision Ascendus is designed for use in clinical settings where real-time ultrasound imaging is essential for diagnostic assessment. It is particularly useful in specialties such as radiology, obstetrics and gynecology, cardiology, vascular studies, and general surgery. The system is intended for trained clinicians like physicians and sonographers who rely on ultrasound for evaluating internal organs, blood flow, fetal development, or soft tissue structures.
Is the HI Vision Ascendus system single-use or reusable, and what does that mean for maintenance and cleaning?
The HI Vision Ascendus is supplied as a reusable medical device, meaning it is built for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. Unlike single-use devices, this system requires adherence to manufacturer guidelines for storage and upkeep to ensure optimal performance and safety. Regular maintenance is necessary to sustain functionality, but specific sterility protocols are not detailed in the provided data.
How is the HI Vision Ascendus system regulated, and what does its FDA clearance status indicate?
The HI Vision Ascendus holds an FDA 510(k) clearance (K153421) under the Radiology advisory committee (RA), classified as a Class II device. The clearance status of *Substantially Equivalent* means the FDA determined it is as safe and effective as a legally marketed predicate device already on the market. This does not imply approval for specific clinical uses but confirms the device meets regulatory standards for diagnostic ultrasound systems.
Are there different models or sizes available for the HI Vision Ascendus, and how would I determine which one fits my needs?
The provided data does not specify distinct models or sizes for the HI Vision Ascendus system, but it is a diagnostic ultrasound system designed for general clinical use. If you require specialized features (e.g., high-frequency transducers for superficial imaging or Doppler for vascular studies), you may need to consult Hitachi Aloka Medical America’s product documentation or sales team. The system’s versatility suggests it can accommodate various clinical applications, but exact configurations would depend on the transducers and accessories included in your purchase.
What storage requirements should I follow for the HI Vision Ascendus to ensure it remains functional and safe?
While the data does not provide explicit sterility or MRI safety details, the HI Vision Ascendus is a reusable device that requires proper storage and maintenance per the manufacturer’s guidelines. This typically includes protecting it from physical damage, extreme temperatures, and environmental contaminants. For long-term storage, it should be kept in a clean, dry environment, and any transducers or accessories should be stored according to their individual instructions to preserve functionality and hygiene.