Ingenia Elition S and Ingenia Elition X— 510(k) K173451
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K173451 for Ingenia Elition S and Ingenia Elition X, Substantially Equivalent on 2018-03-20. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Best Noord-Brabant, NL
Recent devices under product code LNH
view allMore clearances from Philips Medical Systems Nederland B.V.
view all- K254205 — Zenition 30
- K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K173451
K-number listed on FDA's recall record- Z-2395-2023 — Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
- Z-2396-2023 — Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
- Z-2398-2023 — Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
- Z-2399-2023 — Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
- Z-0459-2023 — Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
- Z-0460-2023 — Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
- Z-0461-2023 — Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
- Z-0462-2023 — Philips MR 7700 System, Model Number 782120
- Z-0463-2023 — Philips Upgrade to MR 7700 System, Model Number 782130
- Z-0974-2024 — Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
- Z-2418-2021 — Ingenia Elition 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 orientation of the internal structure of the head, body, or extremities Models: 781357
- Z-2419-2021 — Ingenia Elition X-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 orientation of the internal structure of the head, body, or extremities Models: 781358
- Z-2344-2021 — Ingenia Elition 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 orientation of the internal structure of the head, body or extremities Model Number: 781358
- Z-2347-2021 — Ingenia Elition S-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 orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173451.
Data sourced from openFDA. This site is unofficial and independent of the FDA.