PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR

Solid State X-ray Imager (flat Panel/digital Imager)

PERKINELMER, INC.

The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Perkinelmer, Xrpad 4336 Med Flat Panel Detector.

Pre-market Notification Details

Device IDK140551
510k NumberK140551
Device Name:PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant PERKINELMER, INC. 940 WINTER STREET Waltham,  MA  02451
ContactDawn Spooner
CorrespondentDawn Spooner
PERKINELMER, INC. 940 WINTER STREET Waltham,  MA  02451
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-04
Decision Date2014-08-01
Summary:summary

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