COMET C-125— 510(k) K914748

Substantially Equivalent

Fischer Imaging Corp.

FDA 510(k) clearance K914748 for COMET C-125, Substantially Equivalent on 1992-10-15. Applicant: Fischer Imaging Corp..

Clearance details

Applicant: Fischer Imaging Corp.
Product code: Code OXO
Advisory panel: Radiology
Date received: 1991-10-22
Decision date: 1992-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.