510(k) K030223 ยท LLZ System, Image Processing, Radiological
SONOCALC
| Applicant | Sonometric Health, LLC, Bountiful UT, US |
| Decision | Substantially Equivalent, Feb 6, 2003 |
| Received | Jan 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030223
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2006 | Sonosite, Inc. SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the p Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.