CSP— 510(k) K912448

Substantially Equivalent

Fischer Imaging Corp.

FDA 510(k) clearance K912448 for CSP, Substantially Equivalent on 1991-08-28. Applicant: Fischer Imaging Corp..

Clearance details

Applicant: Fischer Imaging Corp.
Product code: Code OWB
Advisory panel: Radiology
Date received: 1991-06-03
Decision date: 1991-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.