510(k) K092058 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
| Applicant | Sonosite,Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Oct 2, 2009 |
| Received | Jul 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2010 | Sonosite, Inc. The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5).
The software is used with the SonoSite NanoMaxx ultrasound system. Terminated |
IYN | None listed |
| Aug 2, 2010 | Sonosite, Inc. PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.