P50 Series Digital Color Doppler Ultrasound System
510(k) K170999
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK170999 | Date12 Jul 2017 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 18 Sep 2026
The P50 Series Digital Color Doppler Ultrasound System is a diagnostic imaging device classified as a Color Doppler Ultrasound System under the Radiology advisory committee category. It combines digital signal processing and advanced software algorithms to generate high-resolution, real-time imaging for vascular and tissue assessment, enabling clinicians to evaluate blood flow and organ function with precision.
This system is designed for use in clinical, hospital, or diagnostic imaging settings and is supplied as a trolley-mounted unit. The device is single-use or reusable (as per standard ultrasound probe protocols) and adheres to FDA_510K and MDR regulatory standards. It operates in non-MRI environments and is available in multiple floor configurations (4/F, 5/F, 8/F, 9/F, and 10/F). Storage and maintenance follow manufacturer guidelines for ultrasound systems, with no explicit sterility requirements beyond standard probe hygiene protocols.
Other devices from Sonoscape Medical Corp.
Questions
AI-generated answers, 18 Sep 2026
What types of clinical environments is the P50 Series Digital Color Doppler Ultrasound System intended for use in?
The P50 Series is designed for use in clinical, hospital, or diagnostic imaging settings. Its trolley-mounted unit makes it suitable for spaces where portable or semi-fixed imaging is required, such as general wards, outpatient clinics, or dedicated ultrasound labs.
How is the device configured in terms of floor space, and what does this mean for installation?
The P50 Series is available in multiple floor configurations, including 4-foot, 5-foot, 8-foot, 9-foot, and 10-foot models. This flexibility allows facilities to choose a unit that fits their available space while ensuring adequate room for operator movement and patient access during imaging.
Is the P50 Series Digital Color Doppler Ultrasound System compatible with MRI environments?
No, the P50 Series is explicitly designed for use in non-MRI environments. This means it should not be placed in areas where magnetic resonance imaging is performed, as the device may interfere with MRI operations or be affected by magnetic fields.
What are the regulatory pathways for the P50 Series, and how does this affect its availability?
The P50 Series has been authorized through FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming its substantial equivalence to existing devices in its category. This ensures it meets U.S. and EU regulatory standards for safety and performance, supporting its availability in markets where these pathways apply.
Are the ultrasound probes for the P50 Series single-use or reusable, and what hygiene practices should be followed?
The P50 Series follows standard ultrasound probe protocols, meaning probes can be either single-use or reusable depending on manufacturer guidelines. For reusable probes, strict hygiene protocols—such as cleaning, disinfection, and sterilization—must be followed to prevent cross-contamination between patients, as outlined in the manufacturer’s maintenance instructions.