Portable Digital Color Doppler Ultrasound System
by Sonoscape Company Limited 2 variants
510(k) K131088
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131088 | Date24 May 2013 | 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- Withdrawn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, 19 Sep 2026
This device is a Portable Digital Color Doppler Ultrasound System, classified under the nomenclature for diagnostic ultrasound imaging. It combines real-time B-mode imaging with color Doppler functionality to visualize blood flow and tissue structures, enabling non-invasive assessment of vascular and organ systems for diagnostic purposes.
The system is designed for portable use, offering flexibility for point-of-care, obstetrics/gynecology (OB/GYN), gastrointestinal (GI), and cardiac evaluations. Supplied as a reusable medical device, it requires appropriate sterilization or disinfection protocols between uses. Authorized under FDA 510K clearance (K131088) with a Traditional review pathway, it adheres to regulatory standards for diagnostic ultrasound equipment in radiology applications.
Other devices from Sonoscape Company Limited
Questions
AI-generated answers, 19 Sep 2026
What types of medical evaluations is this portable ultrasound system primarily designed for in clinical practice?
This device is specifically designed for non-invasive diagnostic evaluations in portable settings, making it ideal for point-of-care assessments. Its capabilities include obstetrics/gynecology (OB/GYN), gastrointestinal (GI), and cardiac evaluations, as well as general vascular and organ system assessments. The combination of real-time B-mode imaging and color Doppler allows clinicians to visualize both tissue structures and blood flow, which is critical for these specialties.
How is this ultrasound system supplied, and what considerations should be taken for reuse between patients?
The system is supplied as a reusable medical device, meaning it is intended for multiple uses across different patients. To ensure safety and compliance with infection control standards, it must undergo appropriate sterilization or disinfection protocols between uses. This is a standard requirement for reusable diagnostic equipment to prevent cross-contamination and maintain clinical hygiene.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical settings?
This device received FDA clearance through the 510(k) Traditional review pathway, specifically under the Radiology (RA) advisory committee, with a product code of IYN. The clearance determination was that it is substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. Clinically, this indicates that the device has undergone rigorous evaluation to ensure its safety and effectiveness for diagnostic ultrasound imaging as intended.
Is this device portable, and how might its portability benefit clinical workflows?
Yes, this is explicitly described as a portable digital color Doppler ultrasound system, which means it is designed for easy transport and use outside traditional radiology departments. Its portability enables point-of-care evaluations, reducing the need for patients to be transferred to imaging centers and allowing clinicians to perform assessments in emergency rooms, outpatient clinics, or even remote locations. This flexibility can improve efficiency and accessibility in clinical settings.