DeviceClearance

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems— 510(k) K183063

Substantially Equivalent

Philips 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.. 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
Download summary PDFView on FDA.gov ↗

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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 K183063

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183063.

Data sourced from openFDA. This site is unofficial and independent of the FDA.