510(k) K080038 ยท LNH System, Nuclear Magnetic Resonance Imaging
VANTAGE TITAN, MODEL MRT-1504/S3
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Jan 22, 2008 |
| Received | Jan 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2020 | Philips North America, LLC Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-d Terminated |
MWI | None listed |
| Aug 28, 2012 | Toshiba American Medical Systems Inc EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504.
Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Depen Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.