X-ray Flat Panel Detectors/CareView 3600RF

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

CareRay Digital Medical System Co., Ltd.

The following data is part of a premarket notification filed by Careray Digital Medical System Co., Ltd. with the FDA for X-ray Flat Panel Detectors/careview 3600rf.

Pre-market Notification Details

Device IDK202995
510k NumberK202995
Device Name:X-ray Flat Panel Detectors/CareView 3600RF
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant CareRay Digital Medical System Co., Ltd. A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park Suzhou,  CN 215123
ContactLeilei Li
CorrespondentLeilei Li
CareRay Digital Medical System Co., Ltd. A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park Suzhou,  CN 215123
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-01
Decision Date2021-02-19

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