510(k) K162931 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
| Applicant | Philips Medical Systems Nederland B.V., Best, NL |
| Decision | Substantially Equivalent, Jan 6, 2017 |
| Received | Oct 19, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K162931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to dStream for 1.5T;
Model Numbers: (1) 781260, (2) 782112, (3) 782146 Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to dStream for 3.0T;
Model Number: 782145 Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to dStream for XR and 3.0T;
Model Numbers: (1) 781270, (2) 782113; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: SmartPath to Ingenia Elition X;
Model Numbers: (1) 782118, (2) 782144; Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Achieva 1.5T Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Achieva 1.5T Conversion Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Ingenia 1.5T CX Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Intera 1.5T Open, Classified |
LNH | None listed |
| Nov 21, 2023 | Philips North America Llc Intera 1.5T Power/Pulsar Open, Classified |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in a Completed |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orie Completed |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spect Completed |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orie Completed |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/o Completed |
LNH | None listed |
| Jul 30, 2021 | Philips North America Llc Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any Terminated |
LNH | None listed |
| Jul 30, 2021 | Philips North America Llc Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orient Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation Conversion SmarthPath to dStream for 1.5T, Model 781260
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orie Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation Ingenia 1.5T CX, Models 781261 & 781262
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 i Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.