Cleared Traditional

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

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090991 · E-Woo Technology · Radiology device
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Oct 2009
Decision
185d
Days
Class 2
Risk

K090991 is an FDA 510(k) clearance for the COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by E-Woo Technology (Houston, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 185 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Woo Technology devices

Submission Details

510(k) Number K090991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2009
Decision Date October 09, 2009
Days to Decision 185 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 107d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 816
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