Sonoace X8 Diagnostic Ultrasound System
FDA 510(k) K093714 · Medison Co., Ltd.
510(k) numberK093714
Submission
- Device name
- Sonoace X8 Diagnostic Ultrasound System
- Applicant
- Medison Co., Ltd.
Seoul, KR - Received
- December 2, 2009
- Decision date
- December 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| 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 |
|---|---|---|
| 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 |
| K101455 | Eko 7 Diagnostic Ultrasound SystemIYN · Traditional | 07/19/2010SE |
| 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 |
| 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 Sonoace X8 Diagnostic Ultrasound System cleared by the FDA?
Sonoace X8 Diagnostic Ultrasound System (K093714) received a 510(k) decision of Substantially Equivalent on December 10, 2009, 8 days after the submission was received.
What is the product code of K093714?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.