Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei— 510(k) K213516
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K213516 for Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei, Substantially Equivalent on 2022-03-03. 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 K213516
K-number listed on FDA's recall record- Z-1963-2026 — Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
- Z-1969-2026 — Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
- Z-1213-2026 — MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
- Z-1214-2026 — Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
- Z-2207-2025 — Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
- Z-2214-2025 — MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
- Z-1792-2025 — Product Name: Upgrade to MR 7700; Model Number: 782130;
- Z-1805-2025 — Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
- Z-1770-2025 — Enterprise 1.5T, Model Number: 781145;
- Z-1772-2025 — Intera 1.0T Omni/Stellar, Model Number: 781102;
- Z-1776-2025 — Intera 1.5T Master/Nova, Model Number: 781106;
- Z-1782-2025 — SmartPath to dStream for 1.5T, Model Number: 782146;
- Z-1783-2025 — SmartPath to dStream for 3.0T, Model Number: 782145;
- Z-3193-2024 — Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143
- Z-3194-2024 — Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
- Z-3195-2024 — Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
- Z-3196-2024 — Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105
- Z-3197-2024 — Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
- Z-3198-2024 — Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
- Z-3199-2024 — Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213516.
Data sourced from openFDA. This site is unofficial and independent of the FDA.