Sonosite Hand-Carried Ultrasound System (C1 Series)
FDA 510(k) K052109 · Sonosite,Inc.
510(k) numberK052109
Submission
- Device name
- Sonosite Hand-Carried Ultrasound System (C1 Series)
- Applicant
- Sonosite,Inc.
Bothell, WA, US - Received
- August 4, 2005
- Decision date
- August 11, 2005
- 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 |
|---|---|---|
| K113156 | Sonosite Edge Ultrasound SystemIYO · Traditional | 11/15/2011SE |
| 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 |
| K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)IYN · Traditional | 01/12/2005SE |
Questions and answers
When was Sonosite Hand-Carried Ultrasound System (C1 Series) cleared by the FDA?
Sonosite Hand-Carried Ultrasound System (C1 Series) (K052109) received a 510(k) decision of Substantially Equivalent on August 11, 2005, 7 days after the submission was received.
What is the product code of K052109?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.