510(k) K213516 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Mar 3, 2022 |
| Received | Nov 3, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K213516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Philips North America Ingenia Elition S and Ingenia Elition X.;
Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. Open, Classified |
LNH | None listed |
| Sep 25, 2026 | Philips North America MR 7700;
Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199;
Software Versions: R11, R12 and R13; Open, Classified |
LNH | None listed |
| Sep 25, 2026 | Philips North America Upgrade dStream;
Model number (REF): 782127;
Software Versions: R11, R12 and R13; Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc Ingenia Elition S and Ingenia Elition X;
Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X); Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc MR 7700 and Upgrade to MR 7700;
Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X;
Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 ( Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Ingenia Elition X with MR Elastography (MRE).
1. Model Number (REF): 781358.
2. Model Number (REF): 782107.
3. Model Number (REF): 782136.
510(k) Numbers: K213516, K223458, K230972, Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Upgrade to MR 7700 with MR Elastography (MRE).
1. Model Number (REF): 782130. Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America MR 7700.
Product Code (REF): (1) 782120, (2) 782153.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America Upgrade to MR 7700.
Product Code (REF): 782130.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| Jul 30, 2025 | Philips North America Ingenia 3.0T CX
Model Numbers (REF): (1) 781271, (2) 782105; Open, Classified |
LNH | None listed |
| Jul 30, 2025 | Philips North America MR 7700
Model Numbers (REF): (1) 782120, (2) 782153; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: Upgrade to MR 7700;
Model Number: 782130; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: MR 7700;
Model Numbers: (1) 782120, (2) 782153; Open, Classified |
LNH | None listed |
| May 15, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Enterprise 1.5T, Model Number: 781145; Open, Classified |
LNH | None listed |
| May 15, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Intera 1.0T Omni/Stellar, Model Number: 781102; Open, Classified |
LNH | None listed |
| May 15, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Intera 1.5T Master/Nova, Model Number: 781106; Open, Classified |
LNH | None listed |
| May 15, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SmartPath to dStream for 1.5T, Model Number: 782146; Open, Classified |
LNH | None listed |
| May 15, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SmartPath to dStream for 3.0T, Model Number: 782145; 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 |
| Apr 17, 2024 | Philips North America Llc Ingenia Elition S, Magnetic Resonance System. Open, Classified |
LNH | None listed |
| Apr 17, 2024 | Philips North America Llc Ingenia Elition X, Magnetic Resonance System. Open, Classified |
LNH | None listed |
| Apr 17, 2024 | Philips North America Llc MR 7700, Magnetic Resonance System. Open, Classified |
LNH | None listed |
| Feb 1, 2024 | Philips North America Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. Open, Classified |
LNI | None listed |
| Aug 11, 2023 | Philips North America Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X) Open, Classified |
LNH | None listed |
| Aug 11, 2023 | Philips North America Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 Open, Classified |
LNH | None listed |
| Aug 11, 2023 | Philips North America Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X) Open, Classified |
LNH | None listed |
| Aug 11, 2023 | Philips North America Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 Open, Classified |
LNH | None listed |
| Dec 8, 2022 | Philips North America Llc Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 Open, Classified |
LNH | None listed |
| Dec 8, 2022 | Philips North America Llc Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136 Open, Classified |
LNH | None listed |
| Dec 8, 2022 | Philips North America Llc Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 Open, Classified |
LNH | None listed |
| Dec 8, 2022 | Philips North America Llc Philips MR 7700 System, Model Number 782120 Open, Classified |
LNH | None listed |
| Dec 8, 2022 | Philips North America Llc Philips Upgrade to MR 7700 System, Model Number 782130 Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.