Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
FDA 510(k) K213642 · GE Healthcare
510(k) numberK213642
Submission
- Device name
- Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
- Applicant
- GE Healthcare
Wauwatosa, WI, US - Received
- November 18, 2021
- Decision date
- January 13, 2022
- 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 |
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| K213689 | Voluson P6, Voluson P8IYN · Traditional | 02/17/2022SE |
| K211488 | Logiq E10IYN · Traditional | 09/10/2021SE |
| K212004 | MyoSPECT, MyoSpect ESKPS · Traditional | 08/27/2021SE |
Questions and answers
When was Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert cleared by the FDA?
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (K213642) received a 510(k) decision of Substantially Equivalent on January 13, 2022, 56 days after the submission was received.
What is the product code of K213642?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.