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510(k) Data Aggregation
K Number
K082240Device Name
SNTRYPACS
Manufacturer
Date Cleared
2008-11-20
(105 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
QSTAR TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SntryPACS is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.), Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. SntryPACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records. Typical users of the system are trained medical .professionals (e.g. physicians, radiologists)
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.
Device Description
SntryPACS Server is a fully integrated DICOM Storage and DICOM Application Server, compatible with any DICOM modality and most DICOM viewing workstations.
SntryPACS server runs under the QStar storage server environment and provides PACS services such as storage provider and query retrieve provider. Both of these services runs as Linux daemons and utilizes DBMS system and file indexers for managing the medical images and reports. A typical SntryPACS network consists of a central SntryPACS server which stores a database containing the images, and of multiple clients that can retrieve and display these images on medical imaging software. The images are stored in DICOM format. The modalities (MRI, CT, PET, Ultrasounds, etc.) send the images to the PACS Server by using a DICOM "push" (DICOM C-Store). The server and the client workstations communicate by using the DICOM protocol (DICOM C-Store or Query & Retrieve). The clients display the images by using medical imaging software such as a DICOM viewer or a radiology review workstation client software system.
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