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510(k) Data Aggregation
K Number
K111319Device Name
IBIS EXPLORER AND MARKUP SOFTWARE
Manufacturer
MEDQIA
Date Cleared
2011-08-05
(87 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDQIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IBIS Explorer and Markup Software is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including:
- . Oncology, including lesion marking and analysis
- . Anatomic structure marking, volume measurement and analysis
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis.
Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.
Device Description
The IBIS Explorer and Markup Software is a picture archival and communications system (PACS) providing researchers, radiologists or health care professionals with the tools to accept, display, store, archive and manipulate digital medical images. The IBIS Explorer stores, archives and displays digital medical images, while the Markup Software allows for measurements of specified regions and report generation. Digital images supported by the software include but are not limited to bone scans, chest radiograph (x-ray), ultrasound, computed tomography (CT), and magnetic resonance imaqing (MRI).
The System is to be used by trained professionals who are responsible for the correct and accurate use of medical images and the subsequent diagnosis. In a typical clinical environment, the system would be used by a trained technician and radiologist.
The software is installed on an off-the-shelf PC computer system. It is intended to be used with uncompressed digital images that are saved in DICOM format.
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