Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System
FDA 510(k) K101757 · Sonosite,Inc.
510(k) numberK101757
Submission
- Device name
- Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System
- Applicant
- Sonosite,Inc.
Bothell, WA, US - Received
- June 23, 2010
- Decision date
- August 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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 |
| 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 |
|---|---|---|
| K113156 | Sonosite Edge Ultrasound SystemIYO · Traditional | 11/15/2011SE |
| K110645 | Bio Z Cardio Profile Hemodynamic MonitorDSB · Traditional | 06/03/2011SE |
| K102390 | Sonosite Nanomaxx Series Ultrasound SystemIYN · Traditional | 11/19/2010SE |
| K093510 | Lumenvu Catheter Guidance SystemOMF · Traditional | 08/23/2010SE |
| K092058 | Sonosite Nanomaxx Series Ultrasound SystemIYN · Traditional | 10/02/2009SE |
| K082098 | Sonosite Maxx Series Ultrasound SystemIYN · Traditional | 08/25/2008SE |
| K071134 | Sonosite Maxx Series Diagnostic Ultrasound SystemIYO · Traditional | 05/08/2007SE |
| K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)IYN · Traditional | 11/16/2005SE |
| K052109 | Sonosite Hand-Carried Ultrasound System (C1 Series)IYN · Traditional | 08/11/2005SE |
| K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)IYN · Traditional | 01/12/2005SE |
Questions and answers
When was Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System cleared by the FDA?
Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System (K101757) received a 510(k) decision of Substantially Equivalent on August 12, 2010, 50 days after the submission was received.
What is the product code of K101757?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.