510(k) K113541 ยท LLZ System, Image Processing, Radiological
CLEARSTART SVM SYSTEM
| Applicant | Intio, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Dec 16, 2011 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2013 | Intio Inc INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, i Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.