The following data is part of a premarket notification filed by Beijing Crealife Technology Co., Ltd. with the FDA for Anythink Pacs Workstation.
Device ID | K131299 |
510k Number | K131299 |
Device Name: | ANYTHINK PACS WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | BEIJING CREALIFE TECHNOLOGY CO., LTD. ROOM 519, HUITONG COMMERCE BUILDING, B 20 FUXING ROAD Beijing, CN 100036 |
Contact | Weihua Zhou |
Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-05-07 |
Decision Date | 2013-05-22 |
Summary: | summary |