EP-X— 510(k) K934481

Substantially Equivalent

Fischer Imaging Corp.

FDA 510(k) clearance K934481 for EP-X, Substantially Equivalent on 1993-11-03. Applicant: Fischer Imaging Corp..

Clearance details

Applicant: Fischer Imaging Corp.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1993-09-14
Decision date: 1993-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.