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510(k) Data Aggregation
K Number
K131299Device Name
ANYTHINK PACS WORKSTATION
Manufacturer
Date Cleared
2013-05-22
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BEIJING CREALIFE TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Anythink is a medical image processing system, which offers comprehensive solutions to viewing, manipulation, communication and storage of multi-modality DICOM images and data on exchange media.
The Anythink® is a universal imaging platform, and supports different modalities, but it is not intended for the displaying of digital mammography images for diagnosis in the U.S.
Device Description
The Anythink® is based on Windows XP, providing a set of software solutions with flexible configurations in accordance with different medical imaging missions and demands. The system accepts multi-modality DICOM images and allows for view, post-processing, and communication. This product is not intended for use with or for the primary diagnostic interpretation of mammography images in the U.S.
Due to specific customer requirements and the clinical focus, the Anythink® consists of two parts: Basic Functions and Optional Functions.
Basic functions are mandatory, allowing view, easy manipulation, storage and communication of DICOM formatted images, except in the case of mammography images. Management of patient information is also included.
Optional Functions are a set of professional image processing functions, designed for specific modalities. Depending on the precise requirement, customers can select the appropriate function(s) from the optional functions, under the precondition of installing Basic Functions.
The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. The Anythink® is intended to assist the physician in diagnosis or treatment planning.
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