Cleared Special

K041701 - AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM

K041701 is an FDA 510(k) clearance for AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM, manufactured by Agfa Corp.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 30-day FDA review.

K041701 · Agfa Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
30d
Days
Class 2
Risk

K041701 is an FDA 510(k) clearance for the AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on July 22, 2004 after a review of 30 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.

View all Agfa Corp. devices

FDA 510(k) Submission Details - K041701

510(k) Number K041701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2004
Decision Date July 22, 2004
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 281
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K041701.
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K042602 · Ge Medical Systems, LLC · Jan 2005
DIRECT DIGITIZER, REGIUS MODEL 190
K042386 · Konica Minolta Medical & Graphic, Inc. · Dec 2004
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K042023 · Fujifilm Medical System U.S.A., Inc. · Aug 2004
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · Fujifilm Medical System U.S.A., Inc. · Nov 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633 · Canon USA, Inc. · Jun 2003
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
K031447 · Canon, Inc. · May 2003