Cleared Traditional

K131483 - PHILIPS PIXIUM 4343RC

K131483 is the FDA 510(k) clearance for PHILIPS PIXIUM 4343RC by Philips Medical Systems Dmc GmbH. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K131483 · Philips Medical Systems Dmc GmbH · Radiology device
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Oct 2013
Decision
137d
Days
Class 2
Risk

K131483 is an FDA 510(k) clearance for the PHILIPS PIXIUM 4343RC. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Philips Medical Systems Dmc GmbH (Seneca, US). The FDA issued a Cleared decision on October 7, 2013 after a review of 137 days - within the typical 510(k) review window.

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: 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 Philips Medical Systems Dmc GmbH devices

Submission Details

510(k) Number K131483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2013
Decision Date October 07, 2013
Days to Decision 137 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
30d slower than avg
Panel avg: 107d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 219
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