Cleared Special

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

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

About This 510(k) Submission

K161942 is an FDA 510(k) clearance for the PerkinElmer, XRpad2 3025 HWC-M 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 September 1, 2016, 48 days after receiving the submission on July 15, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K161942 FDA.gov
FDA Decision Cleared 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

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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