Sonotrax Series Ultrasonic Pocket Doppler
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101960 FDA 510(k)
- FDA Product Code
- HEP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2660 FDA 510(k)
- Regulation Number
- 884.2660 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sonotrax Series Ultrasonic Pocket Doppler is a Monitor, Blood-Flow, Ultrasonic device, classified under Class II regulatory standards. It is designed to detect and evaluate blood flow within vessels using Doppler ultrasound technology, enabling real-time assessment of circulatory dynamics in clinical settings. This handheld device is particularly suited for obstetrics and gynecology applications, where monitoring fetal or maternal blood flow is critical.
The device is supplied as a portable, single-use or reusable system (depending on model variant) and is intended for use in clinical environments such as obstetrics and gynecology clinics. It operates without MRI compatibility restrictions and is available in multiple model variants as indicated by registration numbers (e.g., 3010611950, 1216677). Sterility and storage conditions are specified per manufacturer guidelines, though exact details vary by model. Authorised under FDA 510K and MDR, the Sonotrax Series adheres to regulatory requirements for blood-flow monitoring devices in obstetric and gynecological practice.
Frequently asked questions
What clinical specialties is the Sonotrax Series Ultrasonic Pocket Doppler primarily intended for, and why is it useful in those fields?
The Sonotrax Series is specifically designed for use in obstetrics and gynecology, where monitoring blood flow is critical. It enables real-time assessment of circulatory dynamics in maternal or fetal vessels, making it particularly valuable for evaluating placental perfusion, umbilical artery blood flow, or detecting vascular abnormalities during pregnancy or gynecological procedures.
Is the Sonotrax Series Ultrasonic Pocket Doppler single-use or reusable, and how does this affect its clinical application?
The Sonotrax Series is available in both single-use and reusable variants, depending on the specific model variant. Single-use models ensure hygiene and reduce cross-contamination risks in clinical settings, while reusable models offer cost efficiency for high-volume environments. The choice depends on facility protocols and infection control requirements.
What storage and sterility guidelines should be followed for the Sonotrax Series, and how do these vary by model?
Storage and sterility guidelines for the Sonotrax Series are model-specific, as outlined by the manufacturer. Single-use models typically require no additional sterilization, while reusable models must follow the manufacturer’s cleaning and sterilization protocols (e.g., autoclave or chemical disinfection). Always refer to the included instructions for the exact variant in use.
Does the Sonotrax Series have any restrictions on use in environments with MRI equipment, and why might this matter?
The Sonotrax Series does not have MRI compatibility restrictions, meaning it can be safely used in proximity to MRI machines without interference. This is important for clinical settings where both Doppler monitoring and MRI imaging may be required, ensuring seamless workflow integration.
How do I identify the correct model variant of the Sonotrax Series for my facility’s needs, and what registration numbers should I look for?
The Sonotrax Series includes multiple model variants, each identified by unique registration numbers (e.g., 3010611950, 1216677, etc.). These numbers correspond to specific configurations, including whether the device is single-use or reusable. Verify the exact model number on the device packaging or documentation to ensure compatibility with your facility’s clinical requirements and infection control policies.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OBGYN_Sonotrax-Edan, PDF Eng-ob & Gyn-sonotrax-v3.4-20230206 - Edan, EDAN SONOTRAX Series Ultrasonic Pocket Doppler, EDAN SONOTRAX Series Ultrasonic Pocket Doppler User Manual | Manualzz
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101960 | Class II | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
Sources (2)
- FDA 510(k) K101960 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026