510(k) K043559 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
| Applicant | Sonosite,Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Jan 12, 2005 |
| Received | Dec 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2011 | Sonosite, Inc. MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound.
General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound im Terminated |
IYN | None listed |
| Oct 1, 2010 | Sonosite, Inc. Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Terminated |
IYN | None listed |
| Oct 1, 2010 | Sonosite, Inc. SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021". Terminated |
IYN | None listed |
| Mar 29, 2007 | Sonosite, Inc. MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.