510(k) K040896 ยท LLZ System, Image Processing, Radiological
MODIFICATION TO ENCOMPASS
| Applicant | Heartlab, Inc., Westerly RI, US |
| Decision | Substantially Equivalent, Jul 16, 2004 |
| Received | Apr 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040896
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2009 | Siemens Medical Solutions, USA, Inc Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235.
Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.