CareView 750Cw/750C X-ray Flat Panel Detectors

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 Careview 750cw/750c X-ray Flat Panel Detectors.

Pre-market Notification Details

Device IDK163019
510k NumberK163019
Device Name:CareView 750Cw/750C X-ray Flat Panel Detectors
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. B3-501, BIOBAY,218 XINGHU STREET SUZHOU INDUSTRIAL PARK Suzhou,  CN 215123
ContactXu Wei
CorrespondentXu Wei
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. B3-501, BIOBAY,218 XINGHU STREET SUZHOU INDUSTRIAL PARK Suzhou,  CN 215123
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-31
Decision Date2016-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970597830363 K163019 000
06970597830349 K163019 000

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