ANYTHINK PACS WORKSTATION

System, Image Processing, Radiological

BEIJING CREALIFE TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Beijing Crealife Technology Co., Ltd. with the FDA for Anythink Pacs Workstation.

Pre-market Notification Details

Device IDK131299
510k NumberK131299
Device Name:ANYTHINK PACS WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant BEIJING CREALIFE TECHNOLOGY CO., LTD. ROOM 519, HUITONG COMMERCE BUILDING, B 20 FUXING ROAD Beijing,  CN 100036
ContactWeihua Zhou
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-05-07
Decision Date2013-05-22
Summary:summary

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