Interson USB Ultrasound System
FDA 510(k) K163443 · Interson Corporation
510(k) numberK163443
Submission
- Device name
- Interson USB Ultrasound System
- Applicant
- Interson Corporation
Pleasanton, CA, US - Received
- December 8, 2016
- Decision date
- April 13, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K233734 | Interson USB Ultrasound SystemIYN · Special | 12/22/2023SE |
| K911116 | Interson Endocavity Probe/Kontron Ultrasound SystITX · Traditional | 12/20/1991SE |
| K911117 | Interson Endocavity Probe for Atl Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911115 | Interson Transrectal Probe/Atl Ultrasound SystemITX · Traditional | 12/17/1991SE |
| K911113 | Interson Transrectal Probe/Kontron Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911114 | Interson Endocavity Probe/Aloka Ultrasound SystemITX · Traditional | 11/19/1991SE |
| K911464 | Interson Disposable Biopsy NeedleIYO · Traditional | 09/27/1991SE |
| K900555 | Interson Multiplane Rectal Probe for Aloka Ultra.ITX · Traditional | 05/02/1990SE |
| K896680 | Probe Sheath for Adms & Capistrano Labs Transrec.FED · Traditional | 02/14/1990SE |
| K895725 | Biopsy Needle Guide for Adms Ultrasound ProbesFCG · Traditional | 11/06/1989SE |
Questions and answers
When was Interson USB Ultrasound System cleared by the FDA?
Interson USB Ultrasound System (K163443) received a 510(k) decision of Substantially Equivalent on April 13, 2017, 126 days after the submission was received.
What is the product code of K163443?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.