I-Rapha Solution

System, Image Processing, Radiological

IRM Inc

The following data is part of a premarket notification filed by Irm Inc with the FDA for I-rapha Solution.

Pre-market Notification Details

Device IDK201296
510k NumberK201296
Device Name:I-Rapha Solution
ClassificationSystem, Image Processing, Radiological
Applicant IRM Inc 4th-D, Myung-Woo Bldg, 169, Yeoksam-ro Gangnam-gu,  KR 06247
ContactKim Yun Ik
CorrespondentKim Yun Ik
IRM Inc. 4th-D, Myung-Woo Bldg, 169, Yeoksam-ro Gangnam-gu,  KR 06247
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-15
Decision Date2020-07-09

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