510(k) K251808 ยท LNH System, Nuclear Magnetic Resonance Imaging
Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
| Applicant | Philips Medical Systems Nederland B.V., Best, NL |
| Decision | Substantially Equivalent, Jul 11, 2025 |
| Received | Jun 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 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 5300;
Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196;
Software Versions: R11, R12 and R13; Open, Classified |
LNH | None listed |
| Sep 25, 2026 | Philips North America SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 7821 Open, Classified |
LNH | None listed |
| Sep 25, 2026 | Philips North America Evolution upgrade 1.5T amd Evolution upgrade 3.0T;
Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T);
Sof Open, Classified |
LNH | None listed |
| Sep 18, 2026 | Philips North America Llc Evolution upgrade 1.5T and Evolution upgrade 3.0T;
Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T); 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 |
| Sep 18, 2026 | Philips North America Llc MR 5300
Model Number (REF): 1. 782110, 2. 782152; 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 Evolution Upgrade 1.5T with MR Elastography (MRE).
1. Model Number (REF): 782116
2. Model Number (REF): 782148.
3. Model Number (REF): 782166. Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Ingenia 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781342.
2. Model Number (REF): 781377.
3. Model Number (REF): 782103.
510(k) Numbers: K163116, K173079, K183063, K193215 Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Ingenia 3.0T CX with MR Elastography (MRE).
1. Model Number (REF): 781271.
2. Model Number (REF): 782105.
510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808. Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips Ingenia Ambition X with MR Elastography (MRE).
1. Model Number (REF): 781356.
2. Model Number (REF): 782109.
3. Model Number (REF): 782138.
4. Model Number (REF): 782160. 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 SmartPath to dStream for XR and 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781270.
2. Model Number (REF): 782113. Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America Evolution Upgrade 1.5T.
Product Codes (REF): (1) 782148, (2) 782116.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.