Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe
FDA 510(k) K131305 · Chison Medical Imaging Co., Ltd.
510(k) numberK131305
Submission
- Device name
- Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe
- Applicant
- Chison Medical Imaging Co., Ltd.
Dublin, CA, US - Received
- May 7, 2013
- Decision date
- August 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYN
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|---|---|---|---|
| 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 |
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| K140364 | Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex…IYN · Traditional | 06/02/2014SE |
| K121867 | Sonotouch Series Diagnostic Ultrasound SystemsIYN · Traditional | 08/02/2012SE |
| K120801 | Chison Diagnostic Ultrasound SystemIYN · Traditional | 06/14/2012SE |
| K113359 | Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex…IYN · Traditional | 02/03/2012SE |
| K091877 | Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array…ITX · Traditional | 09/02/2009SE |
Questions and answers
When was Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe cleared by the FDA?
Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe (K131305) received a 510(k) decision of Substantially Equivalent on August 1, 2013, 86 days after the submission was received.
What is the product code of K131305?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.