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510(k) Data Aggregation
K Number
K042507Device Name
UBIPACS
Manufacturer
Date Cleared
2004-09-27
(12 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ICM CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UbiPACS™ by ICM Co. Ltd. is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
Device Description
The system is a server-based software application. UbiPacs™ is a distributed image management system that manages the archival, retrieval, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. UbiPacs™ provides network access to patients' current and historical radiological images and relevant examination data. The system is designed for facilitating the clinical practice of radiologists and physicians. UbiPacs™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOM-compliant imaging devices such as CT scanners, MR imager, CR systems, digital modalities and image viewing workstations.
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