Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System
FDA 510(k) K102393 · Ge Medical System Israel , Ltd.
510(k) numberK102393
Submission
- Device name
- Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System
- Applicant
- Ge Medical System Israel , Ltd.
Wauwatosa, WI, US - Received
- August 23, 2010
- Decision date
- November 5, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemIYN · Traditional | 08/21/2012SE |
| K121062 | Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemITX · Traditional | 08/17/2012SE |
| K102388 | Vivid I Diagnostic Ultrasound SystemIYN · Special | 11/04/2010SE |
Questions and answers
When was Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System cleared by the FDA?
Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System (K102393) received a 510(k) decision of Substantially Equivalent on November 5, 2010, 74 days after the submission was received.
What is the product code of K102393?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.