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510(k) Data Aggregation
K Number
K051813Device Name
ULTRAPACS
Manufacturer
Date Cleared
2005-08-15
(41 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ULTRARAD CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UltraPACS™ system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA.
Device Description
UltraPACS™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to UltraPACS™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation. The orthopedic application is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The orthopedic application of the device is used to overlay prosthesis templates on radiological images, tools for repositioning the templates. and tools for measurements in the images.
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