DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION— 510(k) K013481

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K013481 for DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION, Substantially Equivalent on 2001-11-02. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code KPR
Advisory panel: Radiology
Date received: 2001-10-19
Decision date: 2001-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.