Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
FDA 510(k) K252328 · GE Medical Systems Ultrasound and Primary Care Diagnostics
510(k) numberK252328
Submission
- Device name
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
Wauwatosa, WI, US - Received
- July 25, 2025
- Decision date
- November 24, 2025
- 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 |
|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | 09/02/2026SE |
| K261668 | Venue GoIYN · Traditional | 08/07/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | 07/30/2026SE |
| K260398 | LOGIQ eIYN · Traditional | 05/26/2026SE |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…IYN · Traditional | 03/24/2026SE |
| K253370 | LOGIQ TotusIYN · Traditional | 01/08/2026SE |
| K253366 | LOGIQ FortisIYN · Traditional | 01/07/2026SE |
| K251985 | Logiq E10IYN · Traditional | 10/29/2025SE |
| K251963 | LOGIQ E10sIYN · Traditional | 10/29/2025SE |
| K251322 | Venue; Venue Go; Venue Fit; Venue SprintIYN · Traditional | 07/25/2025SE |
Questions and answers
When was Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 cleared by the FDA?
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K252328) received a 510(k) decision of Substantially Equivalent on November 24, 2025, 122 days after the submission was received.
What is the product code of K252328?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.