Cleared Special

K013138 - ADC COMPACT PLUS

K013138 is an FDA 510(k) clearance for ADC COMPACT PLUS, manufactured by Agfa-Gevaert AG. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 9-day FDA review.

K013138 · Agfa-Gevaert AG · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
9d
Days
Class 2
Risk

K013138 is an FDA 510(k) clearance for the ADC COMPACT PLUS. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Agfa-Gevaert AG (Rockville, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 9 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 - K013138

510(k) Number K013138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2001
Decision Date September 28, 2001
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
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
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K013138.
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218 · Fujifilm Medical System U.S.A., Inc. · Dec 2001
ADC PEDIATRIC
K012750 · Agfa Corp. · Nov 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238 · Cares Built, Inc. · Oct 2001
SMART RAD
K003438 · Cmt Medical Technologies, Ltd. · Jul 2001
PHORMAX EAGLE SCANNER SYSTEM
K001499 · Phormax Corp. · Dec 2000
PCCR DIGITAL IMAGING DEVICE
K003256 · Orex Computed Radiography, Ltd. · Nov 2000
K013138 · ADC COMPACT PLUS
Download PDF FDA Summary Agfa-Gevaert AG