Terason uSmart3200T Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193510 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 Ultrasound System is a portable diagnostic imaging device classified as an Ultrasound Imaging System (FDA Product Code IYN). It generates real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes. Its design emphasizes portability and ease of use, making it suitable for dynamic clinical environments such as emergency medicine, anesthesia, and critical care settings. The system incorporates advanced signal-processing technology to deliver high-resolution imaging clarity.
The device is supplied as a portable, touch-screen ultrasound scanner with smart gesture controls for streamlined operation. It is intended for single-use or reusable applications in clinical settings, though sterility requirements depend on the specific accessories and probes used. The system adheres to FDA 510(k) clearance (K193510) and EU MDR compliance, ensuring regulatory alignment for use in medical facilities. Storage conditions typically require protection from extreme temperatures and physical damage, with manufacturer guidelines specifying proper handling to maintain functionality.
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: Touch Screen Ultrasound Scanner| Terason 3200t, PDF Terason's Light-Weight, Power-Packed Ultrasound System, Terason 3200t | uSmart Portable Ultrasound Machines | UDS, Terason uSmart3200T Ultrasound System User Guide - 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 | K193510 | Class II | Active |
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Manufacturer
- Manufacturer
- Teratech Corporation
Sources (2)
- FDA 510(k) K193510 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026