Voluson P6, Voluson P8
FDA 510(k) K213689 · GE Healthcare
510(k) numberK213689
Submission
- Device name
- Voluson P6, Voluson P8
- Applicant
- GE Healthcare
Wauwatosa, WI, US - Received
- November 23, 2021
- Decision date
- February 17, 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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| K232346 | Digital Expert Access with Remote ScanningLNH · Traditional | 10/27/2023SE |
| K223212 | Precision DLKPS · Traditional | 04/27/2023SE |
| K221680 | Xeleris V Processing and Review SystemLLZ · Traditional | 03/01/2023SE |
| K221932 | Omni LegendKPS · Traditional | 09/02/2022SE |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYN · Traditional | 01/13/2022SE |
| K211488 | Logiq E10IYN · Traditional | 09/10/2021SE |
| K212004 | MyoSPECT, MyoSpect ESKPS · Traditional | 08/27/2021SE |
Questions and answers
When was Voluson P6, Voluson P8 cleared by the FDA?
Voluson P6, Voluson P8 (K213689) received a 510(k) decision of Substantially Equivalent on February 17, 2022, 86 days after the submission was received.
What is the product code of K213689?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.