510(k) K181479 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia Ambition S and Ingenia Ambition X
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Aug 3, 2018 |
| Received | Jun 5, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K181479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Philips North America Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system Open, Classified |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any o Completed |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any or Completed |
LNH | None listed |
| Jun 4, 2021 | Philips North America Llc Ingenia Ambition X - Model Number: 781356,
Diagnostic MR system.
***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X Open, Classified |
LNH | None listed |
| Jun 4, 2021 | Philips North America Llc Ingenia Ambition S - Model Number: 781359
Diagnostic MR system. Open, Classified |
LNH | None listed |
| Mar 25, 2019 | Philips Medical Systems Nederlands Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED),
Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply p Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.