Q-Rad System

System, X-ray, Stationary

Carestream Health, Inc.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Q-rad System.

Pre-market Notification Details

Device IDK193574
510k NumberK193574
Device Name:Q-Rad System
ClassificationSystem, X-ray, Stationary
Applicant Carestream Health, Inc. Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone,  CN 201206
ContactCarolyn L Wagner
CorrespondentCarolyn L Wagner
Carestream Health, Inc. Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone,  CN 201206
Product CodeKPR  
Subsequent Product CodeLLZ
Subsequent Product CodeMQB
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-01-22

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.