Venue
FDA 510(k) K170714 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
510(k) numberK170714
Submission
- Device name
- Venue
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Wauwatosa, WI, US - Received
- March 9, 2017
- Decision date
- June 21, 2017
- 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
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| K221148 | Vivid iqIYN · Traditional | 07/18/2022SE |
| K203677 | ViewPoint 6LLZ · Special | 01/15/2021SE |
| K200158 | Logiq E10IYN · Traditional | 04/17/2020SE |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18KGI · Traditional | 09/19/2019SE |
| K181934 | Vivid T8, Vivid T9IYN · Traditional | 11/06/2018SE |
| K180782 | AriaKGI · Traditional | 04/20/2018SE |
| K170878 | Vivid S60N, Vivid S70NIYN · Traditional | 06/14/2017SE |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17KGI · Traditional | 12/02/2016SE |
Questions and answers
When was Venue cleared by the FDA?
Venue (K170714) received a 510(k) decision of Substantially Equivalent on June 21, 2017, 104 days after the submission was received.
What is the product code of K170714?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.