Dolphin/IQ, Dolphin/4D and Dolphin/MAX
FDA 510(k) K191023 · Viasonix , Ltd.
510(k) numberK191023
Submission
- Device name
- Dolphin/IQ, Dolphin/4D and Dolphin/MAX
- Applicant
- Viasonix , Ltd.
Ra'Anana, IL - Received
- April 17, 2019
- Decision date
- May 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress)JOP · Traditional | 12/18/2024SE |
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryIYN · Traditional | 01/25/2021SE |
| K192607 | LiteWalkIRP · Traditional | 12/19/2019SE |
| K170859 | Dolphin/IQ and Dolphin/4DIYN · Traditional | 11/14/2017SE |
| K111416 | FalconJOP · Traditional | 07/15/2011SE |
Questions and answers
When was Dolphin/IQ, Dolphin/4D and Dolphin/MAX cleared by the FDA?
Dolphin/IQ, Dolphin/4D and Dolphin/MAX (K191023) received a 510(k) decision of Substantially Equivalent on May 16, 2019, 29 days after the submission was received.
What is the product code of K191023?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.