Ingenia 1.5T CX and Ingenia 3.0T CX R5.3— 510(k) K162931
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K162931 for Ingenia 1.5T CX and Ingenia 3.0T CX R5.3, Substantially Equivalent on 2017-01-06. 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, NL
Recent devices under product code LNH
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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 K162931
K-number listed on FDA's recall record- Z-1788-2025 — Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
- Z-1789-2025 — Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
- Z-1790-2025 — Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
- Z-1791-2025 — Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
- Z-0389-2024 — Achieva 1.5T
- Z-0390-2024 — Achieva 1.5T Conversion
- Z-0392-2024 — Ingenia 1.5T CX
- Z-0393-2024 — Intera 1.5T
- Z-0394-2024 — Intera 1.5T Power/Pulsar
- Z-2412-2021 — Ingenia 1.5T Evolution-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 Model: 781315
- Z-2414-2021 — Ingenia 1.5T CX-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: 781261 781262
- Z-2415-2021 — SmartPath to dStream for 1.5T-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: 781260
- Z-2420-2021 — Ingenia 3.0T CX-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: 781271
- Z-2421-2021 — SmartPath to dStream for XR and 3.0T-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: 781270
- Z-2341-2021 — Ingenia 1.5T Evoluton- 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: 781315
- Z-2345-2021 — Ingenia CX 3.0T-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: 78127 (OUS)
- Z-0901-2019 — Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System
- Z-0902-2019 — Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System
- Z-0904-2019 — Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System
- Z-1436-2018 — Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162931.
Data sourced from openFDA. This site is unofficial and independent of the FDA.