Profile: MIE America, Inc. produces gamma camera systems for nuclear medical diagnostics. We have obtained the EN ISO 9001:2000, EN ISO 13485:2003 + AC: 2007 and FDA certifications. DIACAM® - SCINTRON® VI is a large field SPECT gamma camera suitable for all types of nuclear medicine diagnostic studies. Our SD-X 37 IV - SCINTRON® VI & LFOV - SCINTRON® VI are planar gamma cameras for thyroid & cardiological studies and planar scintigraphy studies, respectively. Our other products include Orbiter®, Bodyscan®, DiacamM®, Multispect® 2 & 3 and ECAM 1 & 2. Equine Scanner H.R. - Scintron® VI is a gamma camera system used in veterinary medicine. We also offer radiation protection products which include tungsten syringe shields, radiation safety-skirt, radiation-safety garbage container and radiation-safety wall with glass. Our accessories include ECG-trigger unit, radionuclide calibrator CRC-25, universal gamma counter CAPRAC R and thyroid-positioner with syringe-holder.
FDA Registration Number: 1423348
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• Emission Computed Tomography System (FDA Code: KPS / 892.1200) An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. |
• Nuclear Scanning Bed (FDA Code: IYZ / 892.1350) A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure. |
• Scintillation Gamma Camera (FDA Code: IYX / 892.1100) A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. |