DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES— 510(k) K913012

Substantially Equivalent

Eigen

FDA 510(k) clearance K913012 for DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES, Substantially Equivalent on 1991-09-23. Applicant: Eigen.

Clearance details

Applicant: Eigen
Product code: Code JAA
Advisory panel: Radiology
Date received: 1991-07-08
Decision date: 1991-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, 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.