PERKINELMER XRD 1622 AP3 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 Xrd 1622 Ap3 Med Flat Panel Detector.

Pre-market Notification Details

Device IDK122495
510k NumberK122495
Device Name:PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
ContactKay A Taylor
CorrespondentKay A Taylor
PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-16
Decision Date2012-11-28
Summary:summary

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