INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100— 510(k) K003853

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K003853 for INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100, Substantially Equivalent on 2001-02-13. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2000-12-12
Decision date: 2001-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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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, 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.