Cleared Special

K161942 - PerkinElmer

K161942 is an FDA 510(k) clearance for PerkinElmer, manufactured by Perkinelmer, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 48-day FDA review.

K161942 · Perkinelmer, Inc. · Radiology device
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Sep 2016
Decision
48d
Days
Class 2
Risk

K161942 is an FDA 510(k) clearance for the PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on September 1, 2016 after a review of 48 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 Perkinelmer, Inc. devices

FDA 510(k) Submission Details - K161942

510(k) Number K161942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2016
Decision Date September 01, 2016
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
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 260
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K161942.
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