510(k) K251397 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
| Applicant | Philips Medical Systems Nederland B.V., Best, NL |
| Decision | Substantially Equivalent, Jun 4, 2025 |
| Received | May 6, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Philips North America Ingenia Blue Seal SE and Blue Seal XE;
Model number (REF): 1. 782185 (SE), 2. 782192 (XE);
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 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 SmartPath to MR 7700;
Model number (REF): 1. 782178, 2. 782207;
Software Versions: R11, R12 and R13; 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 |
| 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 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 S with MR Elastography (MRE).
1. Model Number (REF): 781357.
2. Model Number (REF): 782106.
3. Model Number (REF): 782137. Open, Classified |
LNH | None listed |
| Apr 27, 2026 | Philips North America Philips MR 7700 with MR Elastography (MRE).
1. Model Number (REF): 782120.
2. Model Number (REF): 782153. 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 |
| Apr 27, 2026 | Philips North America Philips SmartPath to Ingenia Elition X with MR Elastography (MRE).
1. Model Number (REF): 782118.
2. Model Number (REF): 782144.
3. Model Number (REF): 782163. 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.