GE Vivid E9 Diagnostic Ultrasound Imaging System
FDA 510(k) K131514 · Ge Vingmed Ultrasound AS
510(k) numberK131514
Submission
- Device name
- GE Vivid E9 Diagnostic Ultrasound Imaging System
- Applicant
- Ge Vingmed Ultrasound AS
Wauwatosa, WI, US - Received
- May 28, 2013
- Decision date
- July 12, 2013
- 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 |
|---|---|---|
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…IYN · Traditional | 03/04/2015SE |
| K150085 | GE EchoPACLLZ · Traditional | 03/02/2015SE |
| K141093 | 6VT-D Ultrasound TransducerITX · Traditional | 05/15/2014SE |
| K131685 | GE EchopacLLZ · Traditional | 09/24/2013SE |
| K123894 | GE EchopacLLZ · Traditional | 01/29/2013SE |
| K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemIYO · Traditional | 04/19/2012SE |
| K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemIYO · Special | 10/13/2010SE |
| K101324 | GE Echopac Model BT10LLZ · Traditional | 10/05/2010SE |
| K092756 | GE Vscan Compact Diagnostic Ultrasound SystemITX · Traditional | 09/28/2009SE |
| K991842 | System Five/Echopac with Strain Rate ImagingIYO · Traditional | 06/11/1999SE |
Questions and answers
When was GE Vivid E9 Diagnostic Ultrasound Imaging System cleared by the FDA?
GE Vivid E9 Diagnostic Ultrasound Imaging System (K131514) received a 510(k) decision of Substantially Equivalent on July 12, 2013, 45 days after the submission was received.
What is the product code of K131514?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.