Terason uSmart 3200T Plus Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201633 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Terason uSmart 3200T Plus Ultrasound System is a portable diagnostic ultrasound device designed for high-resolution imaging. It employs advanced ultrasound technology to generate detailed visualizations of internal body structures, supporting applications in radiology, obstetrics, cardiology, and musculoskeletal assessments. Its design emphasizes clarity and efficiency, leveraging features such as SuperHarmonic Imaging for enhanced tissue differentiation and needle visualization for procedural guidance.
This system is supplied as a reusable medical device, intended for use in clinical, hospital, or outpatient settings. It includes a 1 TB Solid State Drive (SSD) for data storage and features hot-swappable battery capabilities for extended operational use. The device adheres to FDA 510(k) clearance (K201633) and MDR compliance, ensuring regulatory alignment with diagnostic imaging standards. Storage and handling follow standard sterile and non-sterile protocols as dictated by clinical protocols, with no explicit sterility claims.
Frequently asked questions
What clinical specialties is the Terason uSmart 3200T Plus primarily used for, and how does it support those areas?
The Terason uSmart 3200T Plus is designed for high-resolution imaging across multiple specialties, including radiology, obstetrics, cardiology, and musculoskeletal assessments. Its SuperHarmonic Imaging technology enhances tissue differentiation, making it particularly useful for detailed visualization in obstetrics (e.g., fetal imaging) and musculoskeletal evaluations. For cardiology, the system’s clarity aids in assessing heart structures, while radiologists benefit from its precision in soft-tissue imaging and procedural guidance, such as needle visualization for biopsies or injections.
Is the Terason uSmart 3200T Plus a single-use or reusable device, and what does that mean for maintenance and cleaning?
The device is reusable, meaning it is intended for repeated use in clinical, hospital, or outpatient settings after proper cleaning and maintenance. Since it lacks explicit sterility claims, its use follows standard non-sterile protocols as dictated by clinical protocols—this typically involves disinfection between patients to prevent cross-contamination. The manufacturer’s instructions (not provided here) would outline specific cleaning procedures, but reusable ultrasound systems generally require periodic servicing to ensure optimal performance.
How does the battery and storage capacity of the Terason uSmart 3200T Plus support its portability and clinical workflow?
The system features hot-swappable battery capabilities, allowing for extended operational use without downtime for recharging, which is ideal for mobile or outpatient settings. Additionally, it includes a 1 TB Solid State Drive (SSD) for data storage, enabling clinicians to save and transfer imaging data efficiently. This combination of battery flexibility and robust storage enhances workflow continuity, particularly in environments where portability and quick access to patient records are critical.
What regulatory pathways does the Terason uSmart 3200T Plus follow, and how does that affect its use in different markets?
The device holds FDA 510(k) clearance (K201633) under the Radiology product code (IYN) and is MDR-compliant, indicating alignment with both U.S. and European Union regulatory standards. This clearance means it is considered substantially equivalent to a predicate device, allowing it to be marketed in the U.S. without additional clinical trials. For global use, compliance with MDR ensures it meets EU requirements, though additional local registrations or certifications may still be required depending on the country’s specific regulations.
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: uSmart 3200T Plus - Terason, Touch Screen Ultrasound Scanner| Terason 3200t, PDF Terason's Light-Weight, Power-Packed Ultrasound System, Terason uSmart Ultrasounds
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 | K201633 | Class II | Active |
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Manufacturer
- Manufacturer
- Teratech Corporation
Sources (2)
- FDA 510(k) K201633 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026