Terason uSmart3300 Ultrasound System
FDA 510(k) K150148 · Teratech Corp.
510(k) numberK150148
Submission
- Device name
- Terason uSmart3300 Ultrasound System
- Applicant
- Teratech Corp.
Burlington, MA, US - Received
- January 23, 2015
- Decision date
- February 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code IYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
More from Beijing Konted Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
|---|---|---|
| K201633 | Terason uSmart 3200T Plus Ultrasound SystemIYN · Traditional | 07/02/2020SE |
| K193510 | Terason uSmart3200T Ultrasound SystemIYN · Traditional | 01/28/2020SE |
| K150533 | Terason uSmart3200T Ultrasound SystemIYN · Traditional | 05/09/2015SE |
| K140773 | Terason USMART3300 Ultrasound SystemIYN · Traditional | 05/30/2014SE |
| K140834 | Terason USMART3400 Ultrasound SystemIYN · Traditional | 04/25/2014SE |
| K140524 | Terason USMART3200 and Benq UP200ULTRASOUND SystemIYN · Traditional | 03/21/2014SE |
| K131209 | Terason USMART3200T Ultrasound SystemIYN · Traditional | 05/24/2013SE |
| K112953 | Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsIYN · Traditional | 02/03/2012SE |
| K110482 | Prosound C3 / C3 CV Ultrasound SystemsIYN · Traditional | 03/18/2011SE |
| K110020 | Terason T3200 Ultrasound SystemITX · Traditional | 01/20/2011SE |
Questions and answers
When was Terason uSmart3300 Ultrasound System cleared by the FDA?
Terason uSmart3300 Ultrasound System (K150148) received a 510(k) decision of Substantially Equivalent on February 20, 2015, 28 days after the submission was received.
What is the product code of K150148?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.