SC-1000 WITH SUFFIXES (SCAN CONVERTER)— 510(k) K890745

Substantially Equivalent

Eigen

FDA 510(k) clearance K890745 for SC-1000 WITH SUFFIXES (SCAN CONVERTER), Substantially Equivalent on 1989-03-14. Applicant: Eigen.

Clearance details

Applicant: Eigen
Product code: Code JAA
Advisory panel: Radiology
Date received: 1989-02-13
Decision date: 1989-03-14
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.