Prudent 1717, Prudent 1417, Prudent 1212

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

PIXXGEN Corporation

The following data is part of a premarket notification filed by Pixxgen Corporation with the FDA for Prudent 1717, Prudent 1417, Prudent 1212.

Pre-market Notification Details

Device IDK211108
510k NumberK211108
Device Name:Prudent 1717, Prudent 1417, Prudent 1212
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si,  KR 431-804
ContactYoung Kim
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-14
Decision Date2021-06-04

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