510(k) K173356 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia Elition S and Ingenia Elition X R5.4
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Mar 6, 2018 |
| Received | Oct 25, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K173356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Philips North America Ingenia Elition X (Product Number 781358) - 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 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Dec 3, 2018 | Philips Medical Systems Nederlands Ingenia Elition S, Ingenia Elition X Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.