Sonix Ultrasound Scanner
FDA 510(k) K093462 · Ultrasonix Medical Corporation
510(k) numberK093462
Submission
- Device name
- Sonix Ultrasound Scanner
- Applicant
- Ultrasonix Medical Corporation
Richmond, CA - Received
- November 6, 2009
- Decision date
- November 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
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| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K121812 | SonixgpsBSP · Traditional | 12/02/2013SE |
| K111818 | Sonixgps Needle SensorIYO · Traditional | 06/13/2012SE |
| K113663 | Sonixtablet Ultrasound ScannerIYN · Traditional | 01/25/2012SE |
| K112726 | Sonix Ultrasound ScannerIYN · Traditional | 09/27/2011SE |
| K102997 | Sonixtablet Ultrasound ScannerIYN · Traditional | 12/21/2010SE |
| K083095 | Sonixtouch Ultrasound SystemIYN · Traditional | 10/31/2008SE |
| K080935 | Sonix MDP Ultrasound ScannerIYN · Traditional | 08/06/2008SE |
| K061827 | Sonix Ultrasound ScannerIYN · Traditional | 08/04/2006SE |
| K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerIYN · Traditional | 09/16/2004SE |
| K020630 | Ultrasonix Ergosonix 500 Ultrasound ScannerIYN · Traditional | 06/13/2002SE |
Questions and answers
When was Sonix Ultrasound Scanner cleared by the FDA?
Sonix Ultrasound Scanner (K093462) received a 510(k) decision of Substantially Equivalent on November 20, 2009, 14 days after the submission was received.
What is the product code of K093462?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.