Aloka ProSound Alpha 6 Diagnostic Ultrasound System
510(k) K093488
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093488 | Date20 Nov 2009 | 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- Withdrawn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 Aloka ProSound Alpha 6 Diagnostic Ultrasound System is a diagnostic imaging device classified as an ultrasound machine. It generates high-frequency sound waves to create real-time visual images of internal body structures, enabling assessment of organs, tissues, and blood flow for diagnostic purposes. Key features include advanced imaging modes such as 3D/4D imaging, Color Flow 3D, and Multi Slice Imaging (MSI), which enhance diagnostic accuracy and versatility. Automated volume measurement capabilities further support quantitative analysis in clinical evaluations.
This system is designed for use in office-based and clinical settings, providing portable and efficient diagnostic imaging. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accurate performance. The ProSound Alpha 6 adheres to FDA clearance under 510(k) number K093488, with a traditional review process through the Radiology Advisory Committee. No specific sterility or MRI safety information is provided in the available data, though standard infection control protocols should be followed during use.
Other devices from Aloka Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Aloka ProSound Alpha 6 Diagnostic Ultrasound System used for?
The Aloka ProSound Alpha 6 is designed to generate real-time images of internal body structures using high-frequency sound waves. It supports detailed assessment of organs, tissues, and blood flow, with advanced imaging modes like 3D/4D and Color Flow 3D to improve diagnostic accuracy. This makes it ideal for evaluating cardiovascular, obstetric, abdominal, and musculoskeletal conditions in both clinical and office-based environments.
Is the ProSound Alpha 6 a single-use or reusable device?
The ProSound Alpha 6 is a reusable medical device. As a portable and versatile ultrasound system, it requires regular maintenance, calibration, and adherence to standard infection control protocols to ensure reliable performance and patient safety. Reusability extends its utility across multiple procedures and settings.
What are the key imaging features of the ProSound Alpha 6?
The ProSound Alpha 6 includes advanced imaging capabilities such as 3D/4D imaging for volumetric assessments, Color Flow 3D for detailed blood flow visualization, and Multi Slice Imaging (MSI) to enhance diagnostic clarity. These features enable quantitative analysis and improved diagnostic precision for clinicians.
How is the ProSound Alpha 6 supplied and maintained?
The system is supplied as a reusable device, meaning it is intended for repeated use in clinical settings. Proper maintenance—including calibration, cleaning, and adherence to manufacturer guidelines—is essential to sustain performance and accuracy. Aloka provides documentation to support routine upkeep, ensuring the device remains functional for long-term diagnostic use.
Does the ProSound Alpha 6 have any specific sterility requirements?
The available data does not specify sterility requirements for the ProSound Alpha 6 itself, as it is a reusable imaging system rather than a disposable component. However, standard infection control protocols must be followed during use, particularly when handling probes or patient interfaces, to minimize contamination risks and maintain a sterile environment where applicable.