Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems— 510(k) K183063
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K183063 for Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems, Substantially Equivalent on 2019-02-14. Applicant: Philips Medical Systems Nederland B.V..
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Code LNH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Best Noord-Brabant, 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, 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.