Cleared Special

K123644 - VIZION + DR

K123644 is an FDA 510(k) clearance for VIZION + DR, manufactured by Viztek, LLC. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 46-day FDA review.

K123644 · Viztek, LLC · Radiology device
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Jan 2013
Decision
46d
Days
Class 2
Risk

K123644 is an FDA 510(k) clearance for the VIZION + DR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Viztek, LLC (Naples, US). The FDA issued a Cleared decision on January 11, 2013 after a review of 46 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 Viztek, LLC devices

FDA 510(k) Submission Details - K123644

510(k) Number K123644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2012
Decision Date January 11, 2013
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
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
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