510(k) K183063 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Feb 14, 2019 |
| Received | Nov 5, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K183063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Philips North America Ingenia 1.5T, 1.5T CX, and 1.5T S;
Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T),
5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S);
Software Versi Open, Classified |
LNH | None listed |
| Sep 25, 2026 | Philips North America Ingenia 3.0T and 3.0T CX;
Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX);
Software Versions: R11, R12 and R13; Open, Classified |
LNH | None listed |
| Sep 25, 2026 | Philips North America Ingenia Ambition S and Ingenia Ambition X.;
Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 1 Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S;
Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 7812 Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc Ingenia Ambition S and Ingenia Ambition X;
Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X); Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc Ingenia 3.0T and Ingenia 3.0T CX;
Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX); 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 |
| Apr 27, 2026 | Philips North America Philips Ingenia 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781315.
2. Model Number (REF): 781341.
3. Model Number (REF): 781396.
4. Model Number (REF): 782115.
510(k) Numbers: K Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Ingenia 1.5T CX with MR Elastography (MRE).
1. Model Number (REF): 781262. Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips SmartPath to dStream for 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781260.
2. Model Number (REF): 782112. Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America SmartPath to dStream for XR and 3.0T.
Product Code (REF): 781270.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| 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 |
| Feb 2, 2024 | Philips North America Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system 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 |
| 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.