Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex Probe
FDA 510(k) K113359 · Chison Medical Imaging Co., Ltd.
510(k) numberK113359
Submission
- Device name
- Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex Probe
- Applicant
- Chison Medical Imaging Co., Ltd.
Dublin, CA, US - Received
- November 14, 2011
- Decision date
- February 3, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
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| 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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Questions and answers
When was Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex Probe cleared by the FDA?
Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex Probe (K113359) received a 510(k) decision of Substantially Equivalent on February 3, 2012, 81 days after the submission was received.
What is the product code of K113359?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.