Aloka SSD-Alpha 10 Ultrasound System
510(k) K043196
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043196 | Date30 Nov 2004 | 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- Withdrawn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 Aloka SSD-Alpha 10 Ultrasound System is a diagnostic ultrasound device classified under the nomenclature for diagnostic imaging systems. It employs piezoelectric transducers to emit high-frequency sound waves into the body, detecting reflected energy to generate real-time images of internal structures. The system also incorporates Doppler technology to assess blood flow and moving tissues by analyzing shifts in ultrasound frequency. Its primary function is to assist clinicians in visualizing anatomical features and identifying potential abnormalities or pathologies.
This ultrasound system is designed for use in clinical settings by trained operators, including radiologists and sonographers. It is supplied as a reusable medical device and requires appropriate maintenance and calibration to ensure accurate performance. The system is not specified as MRI-safe or sterile upon packaging, and its intended use is limited to diagnostic imaging as defined by its regulatory submission. Authorized for commercial distribution in the United States under an FDA 510(k) clearance (K043196), it adheres to radiology product standards and is intended for single-patient use per session, though reuse is permitted with proper cleaning and sterilization procedures.
Other devices from Aloka Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Aloka SSD-Alpha 10 Ultrasound System?
The Aloka SSD-Alpha 10 Ultrasound System is designed to generate real-time images of internal body structures using high-frequency sound waves emitted by piezoelectric transducers. It also includes Doppler technology to evaluate blood flow and movement within tissues, aiding clinicians in diagnosing anatomical abnormalities or pathologies. This makes it essential for radiologists and sonographers in clinical settings.
How is the Aloka SSD-Alpha 10 Ultrasound System supplied and intended for use?
The system is supplied as a reusable medical device, meaning it is not pre-sterilized or single-use out of the box. It is intended for single-patient use per imaging session but can be reused across multiple sessions with proper cleaning and sterilization procedures. Regular maintenance and calibration are required to ensure accurate performance and reliability.
Is the Aloka SSD-Alpha 10 Ultrasound System MRI-safe?
The device is not specified as MRI-safe in its documentation. If used in an environment with MRI equipment, precautions must be taken to avoid interference or safety risks. Always verify compatibility with the specific MRI system and follow manufacturer guidelines for non-MRI-safe devices.
What regulatory approval does the Aloka SSD-Alpha 10 Ultrasound System hold?
The Aloka SSD-Alpha 10 Ultrasound System holds an FDA 510(k) clearance (K043196), indicating it is deemed substantially equivalent to a legally marketed predicate device. This clearance allows for commercial distribution in the United States under the specified regulatory pathway. The device adheres to radiology product standards.
What maintenance is required to ensure the system performs accurately?
To maintain accuracy and performance, the Aloka SSD-Alpha 10 Ultrasound System requires regular calibration and upkeep as outlined in the manufacturer’s guidelines. Proper cleaning and sterilization procedures must be followed when reusing the device across multiple patients. Adhering to these protocols ensures the system remains reliable for diagnostic imaging and Doppler assessments.