510(k) K230972 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia Elition and MR 7700 MR Systems
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Apr 28, 2023 |
| Received | Apr 5, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230972
| 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 to MR 7700;
Model number (REF): 782130;
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 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 |
| Jan 29, 2026 | Philips North America Ingenia Elition S.
Product Code (REF): (1) 781357, (2) 782106, (3)782137.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America Ingenia Elition X.
Product Code (REF): (1) 781358, (2) 782107, (3) 782136.
MR systems with SW version R11.1 and R12.1. 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 Elition S
Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); Open, Classified |
LNH | None listed |
| Jul 30, 2025 | Philips North America Ingenia Elition X
Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY); 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: Ingenia Elition S;
Model Numbers: (1) 781357, (2) 782106, (3) 782137; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: Ingenia Elition X;
Model Numbers: (1) 781358, (2) 782107, (3) 782136; 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.