Sonosite Edge Ultrasound System
FDA 510(k) K113156 · Sonosite,Inc.
510(k) numberK113156
Submission
- Device name
- Sonosite Edge Ultrasound System
- Applicant
- Sonosite,Inc.
Bothell, WA, US - Received
- October 26, 2011
- Decision date
- November 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| 510(k) | Device | Decision |
|---|---|---|
| K110645 | Bio Z Cardio Profile Hemodynamic MonitorDSB · Traditional | 06/03/2011SE |
| K102390 | Sonosite Nanomaxx Series Ultrasound SystemIYN · Traditional | 11/19/2010SE |
| K093510 | Lumenvu Catheter Guidance SystemOMF · Traditional | 08/23/2010SE |
| K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemITX · Traditional | 08/12/2010SE |
| K092058 | Sonosite Nanomaxx Series Ultrasound SystemIYN · Traditional | 10/02/2009SE |
| K082098 | Sonosite Maxx Series Ultrasound SystemIYN · Traditional | 08/25/2008SE |
| K071134 | Sonosite Maxx Series Diagnostic Ultrasound SystemIYO · Traditional | 05/08/2007SE |
| K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)IYN · Traditional | 11/16/2005SE |
| K052109 | Sonosite Hand-Carried Ultrasound System (C1 Series)IYN · Traditional | 08/11/2005SE |
| K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)IYN · Traditional | 01/12/2005SE |
Questions and answers
When was Sonosite Edge Ultrasound System cleared by the FDA?
Sonosite Edge Ultrasound System (K113156) received a 510(k) decision of Substantially Equivalent on November 15, 2011, 20 days after the submission was received.
What is the product code of K113156?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.