Quality AssuranceApplied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging

The GenASIs Automated Imaging Platforms for Genetic and Pathological Analysis are the foundation of ASI’s offering. With superior imaging and analysis capabilities, ASI provides state of the art diagnostic aids, offering cytogeneticists and pathologists accurate analysis. GenASIs enables automated tissue analysis for primary diagnostics, with reproducible and reliable results. GenASIs Hyperspectral with HiSKY® Probes adds a new dimension to biomedical image analysis.

GenASIs is FDA cleared for FISH clinical applications such as ALK, UroVysion, HER2/neu , CEP XY and Karyotyping.

Applied Spectral Imaging (ASI) - Quality is in Our Genes

ASI’s Quality Management System (QMS) complies with the requirements of ISO 13485, the inline standard requirement for medical devices.  This standard represents the requirements for a comprehensive quality management system for the design, manufacture, export and sales of various medical devices. ASI’s QMS is also harmonized with the ISO 9001 quality standard.

ASI’s activities are compliant with ISO 13485 when it comes to supply, development, operation and maintenance of computer software and related support services.

The continued approval of ASI’s Quality Management System highlights our ongoing commitment to excellence in all of the above areas. All of our software and hardware products are designed, developed, produced, installed and serviced are in compliance with QMS requirements of ISO 9001, and ISO 13485 certified by Intertek, the UK based leading provider of laboratory testing, research, inspection and consulting services for global industry, markets and institutions.

Certifications

• ISO 9001
• ISO 13485 Medical Devices - Quality Management Systems
• ISO 13485 CMDCAS Medical Devices - Quality Management Systems

Regulatory Standards

• 21 CFR 820 for compliance to US code of federal regulation quality systems and IVDD 98/79/EC European In vitro MD directive.

Quality and Regulatory Compliance

ASI conforms to ISO 9001 and ISO 13485 quality standards for medical devices and is fully conversant with HIPAA, Health Insurance Portability and Accountability Act requirements for patient privacy and security.

ASI is FDA cleared as an aid for in-vitro diagnostic procedures of detection of the following:

GenASIs ALK, the world’s first FDA cleared ALK automated gene scanner used for lung cancer therapy selection

GenASIs UroVysion designed for the microscopic imaging and analysis of chromosomal aberrations using fluorescence in situ hybridization (FISH) in urine specimens from persons suspected of having bladder cancer.

GenASIs HER2/neu FISH for in-vitro diagnosis as an aid to the cytogeneticist/pathologist in the deletion, classification, and counting of cells of interest in tissue specimens from breast cancer patients.

GenASIs BandView to be used for karyotyping with real time microscope images from stained metaphases, for Cytogenetics.

GenASIs FISHView to be used for karyotyping with real time microscope images from cultured and stained cell specimens in their metaphase.  In addition, FISHView is intended as an aiding tool for digitally visualizing, processing, counting and classifying stained cells and storing FISH multi-dye images.

GenASIs CEP XY to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.

GenASIs Scan & Analysis was cleared to be used as an adjunctive automated enumeration tool for all the above products.

All other applications are intended For Research Use Only.