Cleared Traditional

K003256 - PCCR DIGITAL IMAGING DEVICE

K003256 is an FDA 510(k) clearance for PCCR DIGITAL IMAGING DEVICE, manufactured by Orex Computed Radiography, Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K003256 · Orex Computed Radiography, Ltd. · Radiology device
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Nov 2000
Decision
22d
Days
Class 2
Risk

K003256 is an FDA 510(k) clearance for the PCCR DIGITAL IMAGING DEVICE. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Orex Computed Radiography, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 - K003256

510(k) Number K003256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2000
Decision Date November 08, 2000
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 300
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K003256.
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