Modification to Viewmate System
FDA 510(k) K073709 · Ep Medsystems
510(k) numberK073709
Submission
- Device name
- Modification to Viewmate System
- Applicant
- Ep Medsystems
West Berlin, NJ, US - Received
- December 31, 2007
- Decision date
- March 11, 2008
- 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 |
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| K092913 | EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04JOQ · Special | 10/16/2009SE |
| K071028 | Viewmate SystemITN · Special | 05/01/2007SE |
| K070706 | Ep-WorkmateDQK · Special | 04/11/2007SE |
| K063277 | MapmateDQK · Special | 11/30/2006SE |
| K063113 | Ep-WorkmateDQK · Special | 10/27/2006SE |
| K041442 | EP-4 Clinical StimutatorJOQ · Special | 09/14/2004SE |
| K033963 | Ep Deflectable CathetersDRF · Special | 04/15/2004SE |
| K040207 | EP-4 Clinical StimulatorJOQ · Special | 02/27/2004SE |
| K031066 | Viewmate Ultrasound Imaging SystemIYN · Traditional | 10/17/2003SE |
| K032225 | Ep-Workmate with RPM SystemDQK · Special | 08/20/2003SE |
Questions and answers
When was Modification to Viewmate System cleared by the FDA?
Modification to Viewmate System (K073709) received a 510(k) decision of Substantially Equivalent on March 11, 2008, 71 days after the submission was received.
What is the product code of K073709?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.