Digital Color Doppler Ultrasound System
by Sonoscape Company Limited 2 variants
510(k) K130801
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130801 | Date14 Jun 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- Withdrawn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
The Digital Color Doppler Ultrasound System is a diagnostic imaging device classified as a Color Doppler Ultrasound System (Device Type: IYN). It combines real-time ultrasound imaging with color Doppler technology to visualize blood flow within vessels and organs, enabling assessment of vascular conditions and organ perfusion. This capability supports clinical evaluations in cardiology, obstetrics, and vascular studies by providing both anatomical and functional information in a single examination.
This system is supplied as a standalone medical device, intended for use in clinical, hospital, or diagnostic imaging settings. It operates with a digital broad-bandwidth beam former and multi-beam parallel processing for enhanced imaging performance. The device is not single-use and requires proper maintenance, including software updates for functionality and stability. No specific sterility or MRI safety information is provided in the specifications, though its use must comply with local regulatory and safety standards.
Other devices from Sonoscape Company Limited
Questions
AI-generated answers, 19 Sep 2026
What clinical specialties would benefit most from using this Digital Color Doppler Ultrasound System, and why?
This system is particularly valuable in cardiology, obstetrics, and vascular studies due to its ability to combine real-time ultrasound imaging with color Doppler technology. This dual capability allows clinicians to visualize both the anatomical structure and functional blood flow within vessels and organs simultaneously, aiding in the assessment of vascular conditions and organ perfusion.
Is this device intended for single-use or repeated use in clinical settings?
The Digital Color Doppler Ultrasound System is not a single-use device. It is designed for repeated use in clinical, hospital, or diagnostic imaging settings, requiring proper maintenance, including software updates to ensure functionality and stability. Regular upkeep is essential to sustain performance over time.
How is this device supplied, and where would it typically be used?
The system is supplied as a standalone medical device, meaning it is not part of a disposable kit or consumable package. It is intended for use in clinical, hospital, or dedicated diagnostic imaging facilities where advanced vascular and organ perfusion assessments are conducted.
Does this device require any special handling or storage conditions?
The specifications do not explicitly detail sterility requirements or special storage conditions, but since it is a reusable device, it must be maintained in accordance with manufacturer guidelines and local regulatory standards. Proper cleaning, calibration, and storage are critical to ensure accurate imaging and longevity.
What type of regulatory pathway was followed for this device’s clearance, and which committee was involved?
The Digital Color Doppler Ultrasound System followed the Traditional 510(k) pathway for FDA clearance, classified under the Radiology advisory committee (RA). The submission was reviewed by the Radiology (RA) Advisory Committee as part of the process to determine substantial equivalence to a predicate device.