COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO— 510(k) K090991

Name: FDA 510(k) clearance K090991
Creator: U.S. Food and Drug Administration
Published: 2009-10-09

Substantially Equivalent

E-Woo Technology

FDA 510(k) clearance K090991 for COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO, Substantially Equivalent on 2009-10-09. Applicant: E-Woo Technology. Device class: 2.

Clearance details

Applicant: E-Woo Technology
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2009-04-07
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.