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

LG Electronics Inc.

The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 10hq701g-b.

Pre-market Notification Details

Device IDK221461
510k NumberK221461
Device Name:10HQ701G-B
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant LG Electronics Inc. 77, Sanho-daero Gumi-si,  KR 39381
ContactJinhwan Jun
CorrespondentWoo Chai Kyoung
GMSC Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul,  KR 03909
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-19
Decision Date2022-07-22

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