510(k) K904908 ยท IYE Accelerator, Linear, Medical
STEREOTACTIC IRRADIATION SYSTEM
| Applicant | Northwest Medical Physics Center, Lynnwood WA, US |
| Decision | Substantially Equivalent, Jun 6, 1991 |
| Received | Oct 31, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | Civco Medical Instruments Inc Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONS
Terminated |
IYE | None listed |
| Aug 9, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software. Terminated |
IYE | None listed |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy. Terminated |
IYE | None listed |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment. Terminated |
IYE | None listed |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software. Terminated |
IYE | None listed |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software. Terminated |
IYE | None listed |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy. Terminated |
IYE | None listed |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.