Cleared Special

K133782 - NOVA FA DR SYSTEM

K133782 is an FDA 510(k) clearance for NOVA FA DR SYSTEM, manufactured by Sedecal., Sa.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 99-day FDA review.

K133782 · Sedecal., Sa. · Radiology device
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Mar 2014
Decision
99d
Days
Class 2
Risk

K133782 is an FDA 510(k) clearance for the NOVA FA DR SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Sedecal., Sa. (Naples, US). The FDA issued a Cleared decision on March 21, 2014 after a review of 99 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 Sedecal., Sa. devices

FDA 510(k) Submission Details - K133782

510(k) Number K133782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2013
Decision Date March 21, 2014
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 259
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