510(k) K041602 ยท LNH System, Nuclear Magnetic Resonance Imaging
PANORAMA 1.0T
| Applicant | Philips Medical Systems North America, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Jul 26, 2004 |
| Received | Jun 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2023 | Philips North America Llc Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device. Open, Classified |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation Panorama 1.0T, Model 781250
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 stru Terminated |
LNH | None listed |
| Mar 1, 2011 | Philips Medical Systems North America Co. Phillips The Panorama HFO system has the Traceable Item Identification (12NC):
9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO).
9896 030 19641-SW R 2.5.3
9896 030 19861-SW R 2.6.1
9 Terminated |
LNH | None listed |
| Dec 21, 2010 | Philips Medical Systems North America Co. Phillips Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit.
Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orie Terminated |
LNH | None listed |
| Jun 27, 2007 | Philips Medical Systems North America Co. Phillips Panorama 1.0T MRI Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.