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510(k) Data Aggregation
K Number
K051639Device Name
AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM
Manufacturer
Date Cleared
2005-08-02
(43 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AS SOFTWARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AS-OBGYN Information System is intended to automate the management of patient information. The system allows image acquisition, review, document, storage, archive and reporting.
The AS-OBGYN Information System is intended for use by obstetricians, gynecologists, perinatologists, radiologists and cardiologists. The system is designed for use in hospitals and medical offices.
Device Description
The AS-OBGYN Information System consists of robust and comprehensive patient information. The system allows the management of patient clinical data and image management (communication, review, storage and archiving). The system provides the capability to edit patient information and clinical data as well as the generation of electronic and printed reports. The device is available in a variety of configurations depending on specific requirements.
The AS-OBGYN Information System communicates with DICOM modalities devices. In the case of DICOM sessions the communication is handled through the AS-DICOM Server package (for TCP/IP connections). For non-DICOM sessions, the communication is handled through the AS-COMM package (for TCP/IP, RS-232 and USB connections). The AS-OBGYN Information System receives single and multi-frame images from devices over the network using the DICOM communication, while additional descriptive data may be received through DICOM session or non-DICOM sessions.
All the hardware used by AS-OBGYN Information System (including computers, storage drives, network interface, monitor and printer) is commercial off-the-shelf equipment.
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