Cleared Special

K133106 - COMPUTED RADIOGRAPHY SCANNER

K133106 is an FDA 510(k) clearance for COMPUTED RADIOGRAPHY SCANNER, manufactured by 3Disc Americas. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 107-day FDA review.

K133106 · 3Disc Americas · Radiology device
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Jan 2014
Decision
107d
Days
Class 2
Risk

K133106 is an FDA 510(k) clearance for the COMPUTED RADIOGRAPHY SCANNER. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by 3Disc Americas (Naples, US). The FDA issued a Cleared decision on January 15, 2014 after a review of 107 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3Disc Americas devices

FDA 510(k) Submission Details - K133106

510(k) Number K133106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date January 15, 2014
Days to Decision 107 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
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 289
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K133106.
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K133409 · Rayence Co., Ltd. · Feb 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509 · Fujifilm Medical Systems U.S.A, Inc. · Nov 2013
PHILIPS PIXIUM 4343RC
K131483 · Philips Medical Systems Dmc GmbH · Oct 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
K131114 · Rayence Co., Ltd. · Sep 2013