X-ray Imaging. Compliance Consultants' earliest projects were ionizing radiation sources - contained within liquid cooled, lead lined, x-ray tubes with rotating anodes. We matured into collimators, film cassettes, collimators, exposure controls, patient handling systems and x-ray generators.


Compliance Consultants worked on both for regulatory and engineering projects on ionizing (x-ray tube technology) and non- ionizing (fluroscopy) imaging systems. Involved in early Computerized Axial Tomography systems as well as early soft issue (low-dose) digital imaging/enhancement systems using array processors.


We were at the forefront when digital radiography was first conceived adapting array processors to render digital images from vascular angiography. We matured into other imaging modalities...fluoroscopy, ultrasound, CAT scanners, MRI, PET, ....these mature products have derivative that include vessel analysis and calcium scoring softwar...Regulation Number: 21 CFR 892.2050, Product Code: LLZ


Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices

http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm073781.pdf