510(k) K945945 ยท LNH System, Nuclear Magnetic Resonance Imaging
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
| Applicant | Philips Medical Systems North America, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Dec 22, 1995 |
| Received | Dec 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2018 | Philips Electronics North America Corporation T5-NT, 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 Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation ACS-NT, Model 78108
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 Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation T10-NT, Model 78107
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 Terminated |
LNH | None listed |
| Feb 26, 2016 | Philips Electronics North America Corporation SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system Terminated |
LNH | None listed |
| Jun 27, 2007 | Philips Medical Systems North America Co. Phillips Gyroscan MRI Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.