PIXELL MRI SYSTEM— 510(k) K962249

Substantially Equivalent

General Medical Equipment Corp.

FDA 510(k) clearance K962249 for PIXELL MRI SYSTEM, Substantially Equivalent on 1997-01-10. Applicant: General Medical Equipment Corp..

Clearance details

Applicant: General Medical Equipment Corp.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1996-06-11
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sound Beach, NY, 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.