Eko 7 Diagnostic Ultrasound System
FDA 510(k) K101455 · Medison Co., Ltd.
510(k) numberK101455
Submission
- Device name
- Eko 7 Diagnostic Ultrasound System
- Applicant
- Medison Co., Ltd.
Seoul, KR - Received
- May 25, 2010
- Decision date
- July 19, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K103397 | Accuvix XG Diagnostic Ultrasound SystemIYN · Traditional | 02/25/2011SE |
| K103722 | The Sonoace R5 Diagnostic Ultrasound SystemITX · Traditional | 01/05/2011SE |
| K102065 | Sonoace R7 Diagnostic Ultrasound SystemIYN · Traditional | 08/06/2010SE |
| K101829 | The Sonoace R3 Diagnostic Ultrasound SystemITX · Traditional | 07/16/2010SE |
| K100186 | Mysono U5 Diagnostic Ultrasound SystemIYN · Traditional | 03/24/2010SE |
| K093849 | Accuvix V10 Diagnostic Ultrasound SystemIYN · Traditional | 01/19/2010SE |
| K093714 | Sonoace X8 Diagnostic Ultrasound SystemITX · Traditional | 12/10/2009SE |
| K092159 | Accuvix V20 Diagnostic Ultrasound SystemIYN · Traditional | 07/28/2009SE |
| K081676 | Sonoace X6 Diagnostic Ultrasound SystemIYN · Traditional | 07/02/2008SE |
| K080800 | Accuvix V20 Diagnostic Ultrasound SystemIYN · Traditional | 04/07/2008SE |
Questions and answers
When was Eko 7 Diagnostic Ultrasound System cleared by the FDA?
Eko 7 Diagnostic Ultrasound System (K101455) received a 510(k) decision of Substantially Equivalent on July 19, 2010, 55 days after the submission was received.
What is the product code of K101455?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.