Cleared Special

PerkinElmer, XRpad 4343 F MED Flat Panel Detector

K142698 · Perkinelmer, Inc. · Radiology
Oct 2014
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K142698 is an FDA 510(k) clearance for the PerkinElmer, XRpad 4343 F MED Flat Panel Detector, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on October 23, 2014, 31 days after receiving the submission on September 22, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K142698 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2014
Decision Date October 23, 2014
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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