Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal
FDA 510(k) K091877 · Chison Medical Imaging Co., Ltd.
510(k) numberK091877
Submission
- Device name
- Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal
- Applicant
- Chison Medical Imaging Co., Ltd.
Dublin, CA, US - Received
- June 23, 2009
- Decision date
- September 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ITX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| 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 |
|---|---|---|
| K170870 | Site~Rite Halcyon Diagnostic Ultrasound SystemIYN · Traditional | 07/06/2017SE |
| K170374 | SonoBook Series Diagnostic Ultrasound SystemIYN · Traditional | 06/06/2017SE |
| K162172 | EBit Series Diagnostic Ultrasound SystemIYN · Traditional | 09/14/2016SE |
| K153085 | Q Series Diagnostic Ultrasound SystemIYN · Traditional | 12/21/2015SE |
| K150861 | QBit Series Diagnostic Ultrasound SystemIYN · Traditional | 07/28/2015SE |
| K140364 | Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex…IYN · Traditional | 06/02/2014SE |
| K131305 | Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased ProbeIYN · Traditional | 08/01/2013SE |
| K121867 | Sonotouch Series Diagnostic Ultrasound SystemsIYN · Traditional | 08/02/2012SE |
| K120801 | Chison Diagnostic Ultrasound SystemIYN · Traditional | 06/14/2012SE |
| K113359 | Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex…IYN · Traditional | 02/03/2012SE |
Questions and answers
When was Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal cleared by the FDA?
Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal (K091877) received a 510(k) decision of Substantially Equivalent on September 2, 2009, 71 days after the submission was received.
What is the product code of K091877?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.