510(k) K253648— 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

Philips Medical Systems Nederland B.V.

Clearance details

Applicant: Philips Medical Systems Nederland B.V.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2025-11-20
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Best, NL

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, 2020-01-01 through 2026-04-23. 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.