510(k) K890789 ยท LNH System, Nuclear Magnetic Resonance Imaging
GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
| Applicant | Philips Medical Systems North America, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Apr 28, 1989 |
| Received | Feb 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2018 | Philips Electronics North America Corporation T5 Model 78104
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.