Cleared Traditional

K032654 - PORT CASSETTE

K032654 is an FDA 510(k) clearance for PORT CASSETTE, manufactured by Orex Computed Radiography, Ltd.. The device is a Class 2 Radiology device with product code IXK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K032654 · Orex Computed Radiography, Ltd. · Radiology device
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Oct 2003
Decision
42d
Days
Class 2
Risk

K032654 is an FDA 510(k) clearance for the PORT CASSETTE. Classified as System, Imaging, X-ray, Electrostatic (product code IXK), Class II - Special Controls.

Submitted by Orex Computed Radiography, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1630 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orex Computed Radiography, Ltd. devices

FDA 510(k) Submission Details - K032654

510(k) Number K032654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2003
Decision Date October 09, 2003
Days to Decision 42 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
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXK Device Classification - Class 2, Special Controls

Product Code IXK System, Imaging, X-ray, Electrostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1630
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 - IXK System, Imaging, X-ray, Electrostatic

All 8
Devices cleared under the same product code (IXK) and FDA review panel - the closest regulatory comparables to K032654.
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