E-SPEED EBT SCANNER SYSTEM— 510(k) K022794

Name: FDA 510(k) clearance K022794
Creator: U.S. Food and Drug Administration
Published: 2002-10-11

Substantially Equivalent

Ge Imatron

FDA 510(k) clearance K022794 for E-SPEED EBT SCANNER SYSTEM, Substantially Equivalent on 2002-10-11. Applicant: Ge Imatron. Device class: 2.

Clearance details

Applicant: Ge Imatron
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2002-08-23
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Fransisco, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.