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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K133106.
FLAATZ 600 SERIES (FLAATZ 600/601)
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K132509 · Fujifilm Medical Systems U.S.A, Inc. · Nov 2013
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K131211 · Oehm Und Rehbein GmbH · Nov 2013