PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

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 Pixx 1717; Pixx 1417; Pixx 1212; Digital Diagnostic X-ray Receptor Panels.

Pre-market Notification Details

Device IDK182533
510k NumberK182533
Device Name:PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Pixxgen Corporation 5F, Smart Bay, 123, Beolmal-ro, Dongan-gu Anyang-si,  KR 14056
ContactJohn Ross
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 Received2018-09-14
Decision Date2018-10-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809378240177 K182533 000
08809378240160 K182533 000
08809378240153 K182533 000
08809378240122 K182533 000
08809378240115 K182533 000
08809378240108 K182533 000

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