510(k) K072374 ยท IYE Accelerator, Linear, Medical
COMPASS
| Applicant | Scanditronix Wellhofer GmbH, Schwarzenbruck, DE |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Aug 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072374
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2015 | Iba Dosimetry Gmbh COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological Terminated |
IYE | None listed |
| Nov 4, 2014 | Iba Dosimetry Gmbh COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological Terminated |
IYE | None listed |
| Dec 6, 2013 | Iba Dosimetry Gmbh iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator)
radiological Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.