510(k) K212673 ยท LNH System, Nuclear Magnetic Resonance Imaging
MR 5300
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Nov 19, 2021 |
| Received | Aug 24, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K212673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2025 | Philips North America MR 5300
Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: MR 5300;
Model Numbers: (1) 782110, (2) 782152; Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orienta Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
(REF Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
(RE Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
(REF) N Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
(REF) Nu Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, Open, Classified |
LNH | None listed |
| Sep 20, 2024 | Philips North America Llc SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 782152
(2) 782110 Open, Classified |
LNH | None listed |
| Apr 17, 2024 | Philips North America Llc MR 5300, Magnetic Resonance System. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.