Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System
FDA 510(k) K121062 · Ge Medical System Israel , Ltd.
510(k) numberK121062
Submission
- Device name
- Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System
- Applicant
- Ge Medical System Israel , Ltd.
Wauwatosa, WI, US - Received
- April 6, 2012
- Decision date
- August 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ITX
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| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
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| K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional | Olympus Medical Systems Corporation | 09/18/2025SE |
| K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional | Olympus Medical Systems Corporation | 07/11/2025SE |
| 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 |
|---|---|---|
| K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemIYN · Traditional | 08/21/2012SE |
| K102393 | Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound SystemIYO · Special | 11/05/2010SE |
| K102388 | Vivid I Diagnostic Ultrasound SystemIYN · Special | 11/04/2010SE |
Questions and answers
When was Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System cleared by the FDA?
Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System (K121062) received a 510(k) decision of Substantially Equivalent on August 17, 2012, 133 days after the submission was received.
What is the product code of K121062?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.