510(k) K213583 ยท LNH System, Nuclear Magnetic Resonance Imaging
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, May 16, 2022 |
| Received | Nov 12, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K213583
| 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 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 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 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 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 Evolution upgrade 3.0T with MR Elastography (MRE).
1. Model Number (REF): 782143.
2. Model Number (REF): 782162. 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 Ambition S with MR Elastography (MRE).
1. Model Number (REF): 781359.
2. Model Number (REF): 782108.
3. Model Number (REF): 782139. 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 SmartPath to dStream for 3.0T with MR Elastography (MRE).
1. Model Number (REF): 782145. 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 |
| 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 |
| 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 |
| Jan 29, 2026 | Philips North America Evolution Upgrade 3.0T.
Product Code (REF): 782143.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America Ingenia Ambition X.
Product Code (REF): (1) 781356, (2) 782109, (3)782138.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| Jan 29, 2026 | Philips North America SmartPath to dStream for 3.0T.
Product Code (REF): 782145.
MR systems with SW version R11.1 and R12.1. Open, Classified |
LNH | None listed |
| Jul 30, 2025 | Philips North America Ingenia 1.5T
Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; Open, Classified |
LNH | None listed |
| Jul 30, 2025 | Philips North America Ingenia Ambition S
Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; Open, Classified |
LNH | None listed |
| Jul 30, 2025 | Philips North America Ingenia Ambition X
Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: Ingenia 1.5T;
Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: Ingenia Ambition S;
Model Numbers: (1) 781359, (2) 782108, (3) 782139; Open, Classified |
LNH | None listed |
| May 16, 2025 | Philips North America Llc Product Name: Ingenia Ambition X;
Model Numbers: (1) 781356, (2) 782109, (3) 782138; Open, Classified |
LNH | None listed |
| Jun 4, 2024 | Philips North America Llc HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system,
Product Number: 989710006411 Open, Classified |
LNH | None listed |
| Jun 4, 2024 | Philips North America Llc HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system,
Product Number: 989710006412 Open, Classified |
LNH | None listed |
| Jun 4, 2024 | Philips North America Llc HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system,
Product Number: 989710008732 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Ingenia Ambition S
Model Number (REF):
(1) 782139;
(2) 782133;
(3) 782108;
(4) 781359 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 782138;
(2) 782109;
(3) 781356 Open, Classified |
LNH | None listed |
| Apr 17, 2024 | Philips North America Llc Ingenia Ambition S, Magnetic Resonance System. Open, Classified |
LNH | None listed |
| Apr 17, 2024 | Philips North America Llc Ingenia Ambition X, Magnetic Resonance System. 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 |
| Jan 11, 2024 | Philips North America (1) Ingenia Ambition X (Product Number 781356);
(2) Ingenia Ambition S (Product Number 781359) Open, Classified |
LNI | None listed |
| Aug 11, 2023 | Philips North America MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) Open, Classified |
LNH | None listed |
| Aug 11, 2023 | Philips North America MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.