Cleared Special

K053634 - COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION

K053634 is an FDA 510(k) clearance for COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0..., manufactured by Agfa Corporation. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 19-day FDA review.

K053634 · Agfa Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
19d
Days
Class 2
Risk

K053634 is an FDA 510(k) clearance for the COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Agfa Corporation (Greenville, US). The FDA issued a Cleared decision on January 17, 2006 after a review of 19 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K053634

510(k) Number K053634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2005
Decision Date January 17, 2006
Days to Decision 19 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 423
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K053634 · COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
Download PDF FDA Summary Agfa Corporation