Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades— 510(k) K253648
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K253648 for Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades, Substantially Equivalent on 2026-02-23. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Summary
Philips Medical Systems Nederland's device name covers several MR systems: Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300, and MR 7700, "including Upgrades." It's filed under product code LNH, nuclear magnetic resonance imaging system. The record doesn't describe the systems beyond that name and code name.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as an Abbreviated 510(k).
Philips filed from Best, Netherlands. The decision came 95 calendar days after FDA received it (November 20, 2025 to February 23, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Product 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.