510(k) K023373 ยท IYX Camera, Scintillation (Gamma)
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
| Applicant | Gvi Technology Partners, Twinsburg OH, US |
| Decision | Substantially Equivalent, Jan 3, 2003 |
| Received | Oct 8, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2004 | GVI Technology Partners CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech. Terminated |
IYX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.