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QDOSE® Multi-purpose Voxel Dosimetry is indicated for use to provide estimates of radiation absorbed dose to organs and tissues of the body from medically administered radiopharmaceuticals, and to calculate total-body effective dose. Radiation absorbed dose calculations are based on clinical measurements of radioactivity biodistributions and biokinetics. QDOSE® is intended for applications in clinical nuclear medicine, molecular radiotherapy, radiation safety evaluations, risk assessment, record-keeping, and regulatory compliance. QDOSE® is indicated for use by professionals (medical physicists, radiologists and oncologists including nuclear medicine physicians), radiologic imaging technologists, health physicists and radiation safety officers and administrators, students in training, and others having interest in ability to calculate internal radiation doses from medically administered radiopharmaceuticals.

QDOSE® is a software package for calculating internal radiation doses from clinically administered radiopharmaceuticals. Patient time-activity data may be imported to QDOSE® in DICOM files from nuclear medicine clinical imaging. Dosimetry performed within QDOSE® is based on the use of calculated S values, determined for patient-like phantoms using a Monte Carlo method. The S values provide the average absorbed dose to a target organ generated by a unit of activity in a source organ time-activity curves from quantitative nuclear medicine imaging data are integrated to yield an estimate of the number of radionuclide decays representing the area under a time-activity function, similarly to the mathematical process used by OLINDA/EXM. QDOSE® dose calculations are performed by multiplying a source organ timeactivity curve integral by the S value generated from Monte Carlo calculations. The product of the dose calculations is an output of radiation absorbed doses to specified target organs per unit administered activity.

The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and or fused CT or MR scans, and with physiological sigmals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scamed body tissue for clinical diagnostic purposes. The DaTQUANT optional application enables visual evaluation and quantification of 1231-ioflupane (DaTscanTM) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 1231-ioflupane (DaTscanTM) images. These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease. The Q.Lung AI application may aid physicians in: -Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies. -Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe, bilobectomy, or pneumonectomy. The Q.Brain application allows the user to visualize and quantify relative changes in the brain's metabolic function or blood flow activity between a subject's images and controls, which may be resulting from brain functions in: -Epileptic seizures -Dementia. Such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, vascular dementia, and frontotemporal dementia. -Inflammation -Brain death -Cerebrovascular disease such as Acute stroke, Chronic and acute ischemia -Traumatic Brain Injury (TBI) When integrated with the patient's clinical and diagnostic information may aid the physician in the interpretation of cognitive complaints, neuro-degenerative disease processes and brain injuries. The Alcyone CFR application allows for the quantification of coronary vascular function by deriving Myocardial Blood Flow (MBF) and then calculating Coronary Flow Reserve (CFR) indices on data acquired on PET scamers and on stationary SPECT scanners with the capacity for dynamic SPECT imaging. These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD). The Exini Bone application is intended to be used with NM bone scans for the evaluation of adult male patients with bone metastases from prostate cancer. Exini Bone quantifies the selected lesions and provides a Bone Scan Index value as adjunct information related to the progression of disease. The Q.Liver application provides processing, quantification, and multidimensional review of Liver SPECT/PET and CT images for display, segmentation, and a calculation of the SPECT 'liver to lune' shunt value and the patient's Body Surface Area (BSA) for use in calculating a therapeutic dose for Selective Internal Radiation Therapy (SIRT) treatment using a user defined formula. The O.Thera AI application allows physicians review and monitor patient radiation doses derived from nuclear medicine imaging data, including SPECT/CT, PET/CT, and Whole-body Planar images, and from biological samples from the patient. The application provides estimates of isotope residence time, absorbed dose, and equivalent dose at the whole organ level, as well as estimates of whole-body effective dose. The output from Q.Thera AI may aid physicians in monitoring patient radiation doses. For use with internally administered radioactive products. O.Thera AI should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing informations.

Xeleris V Processing and Review System is a Nuclear Medicine Software system that is designed for general nuclear medicine processing and review procedures for detection of radioisotope tracer uptake in the patient's body, using a variety of individual processing applications orientated to specific clinical applications. It includes all of the clinical applications and features in the current production version of the predicate Xeleris V and, introduces two clinical applications Q.Thera AI: The Q.Thera Al application allows physicians review and monitor patient radiation doses derived from nuclear medicine imaging data, including SPECT/CT, and Whole-body Planar images, and from biological samples from the patient. The application provides estimates of isotope residence time, absorbed dose, and equivalent dose at the whole organ level, as well as estimates of whole-body effective dose. The output from Q.Thera Al may aid physicians in monitoring patient radiation doses. Q.Thera AI is a modification to the predicate's Dosimetry Toolkit application for enhancing site's dosimetry workflow through the following updates: - Image Pre-Processing: Q.Thera Al uses the predicate's Q.Volumetrix MI application for image preprocessing, bringing additional automated organ segmentations as well as enabling dosimetry on PET/CT imaging data. - Dosimetry Calculations: Q.Thera Al adds calculation of radiation doses to Dosimetry Toolkit's previous determination of isotope residence time. Similar to the reference Olinda/EXM (K163687), the added calculations follow the guidelines published by the Medical Internal Radiation Dose (MIRD) committee of the Society of Nuclear Medicine (SNM) and models from publication Nº 89 of the International Commission on Radiological Protection (ICRP). Generate Planar: The Generate Planar application produces 2D derived planar images from 3D SPECT images that are acquired using GE Healthcare's StarGuide SPECT-CT system (K210173). Generate Planar was first cleared on Xeleris 4.0 (K153355). It was also included in StarGuide's 510(k) clearance for producing derived planar images from hybrid SPECT-CT studies. Xeleris V brings the Generate Planar application from Xeleris 4.0 and expands it to also produce derived planar images from SPECT-only studies.

3D-RD-S is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administrated radioactive products, 3D-RD-S should not be used to deviate from product dosing and administrations. Refer to the product's prescribing information for instructions.

3D-RD-S is a cloud-based software as a medical device (SaMD) that interacts with the user via web browsers (for example Google Chrome). Users are trained healthcare professionals with significant dosimetry knowledge and experience and also responsible for the input of the appropriate values and to make correct interpretation of the output data. 3D-RD-S takes numerical input data in the form of activity in source tissues as a function of time (TAC data) or the integral of the activity (TIA data) in source tissues over time. It then calculates the absorbed dose to a set of target tissues based on the organ sizes and anatomies of a set of standard phantoms. The software provides the user the ability to account for the differences in tissue masses between the phantoms and the subject and model uncertainties in the input data. Calculation results can be viewed and updated by other users. The software provides the ability to calculate absorbed doses and related radiobiological quantities from input data. The calculations can be made for supported radionuclides based on data in the report 89 from the International Council on Radiation Protection (ICRP). Doses to target tissues are a function of the activity integrated over time (time-integrated activity. TIA) in a set of specified source organs. The software provides two modules for the integration of input time vs. activity curve (TAC) data. First, the user can use curve fitting methods to estimate a curve that passes through the TAC data from a set of supported fitting functions. Visual and numerical indicators of how well the fitting function works with the data are provided. Notifications are given if fitting parameters are non-physical. The TAC data can then be integrated using the fitting function, or by approximating the activity between measured time points with line and assuming activity after the last time-point decays with the radionuclide's physical half-life. If desired, the user can use a combination of the curve fit, linear interpolation between the lines, and exponentially decaying extrapolation based on the physical half-life, to integrate the time-activity curves. The calculated radiobiological quantities purport to relate physical dose to biological response and are dependent on the specification of radiobiological constants. The guantities supported include the whole-body effective dose and the relative biological effectiveness (RBE) weighted dose. The effective dose is calculated based on ICRP tissue weighting factors. The RBE weighted dose is calculated using user specified RBEs for the different radiation types (standard values are provided as defaults). 3D-RD-S provides total and individual dose estimates for the various particle types, i.e., alpha particles, beta (+ and -) particles, discrete electrons (e.g., Auger electrons), and photons (gamma and x-rays). The resulting doses are plotted in a bar graph and can, along with input data, be exported in a spreadsheet.

The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.

The OLINDA/EXM® v2.0 is a modification of OLINDA/EXM® v1.1 (K033960) and includes new human models and nuclides. OLINDA/EXM® 2.0 employs a new set of decay data recommended by the International Commission on Radiological Protection (ICRP). OLINDA/EXM® 2.0 introduces a new series of anthropomorphic human body models (phantoms), so new values of Specific Absorbed Fractions (SAF), di (T←S) were generated. These phantoms were based on updated values of the mass of the target region (mr) recommended by the ICRP. The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).

The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200ke V for the detection and display of radioisotope tracer uptake in patients of all ages. When used with the optional Discovery NM 750b Biopsy system, the Discovery NM 750b is designed to accurately locate, in three dimensions, lesions in the breast using information derived from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes such as biopsy and pre-surgical localization.

The Discovery NM 750b Biopsy system is an optional accessory for the Discovery NM 750b gamma camera (K102231) that utilizes stereotactic imaging to help guide invasive procedures. It is intended for 3D lesion localization to provide the physician image guidance for vacuum assisted needle biopsy of breast lesions determined to be suspicious through molecular breast imagine or other imaging. The Biopsy system uses a pair of CZT "biopsy" detectors with fixed stereotactic positions. These two detectors acquire pair of anqulated two-dimensional images that are used in determining the 3D localization of the pre-identified suspicious lesion. The Discovery NM750b Biopsy system includes hardware and software components, which auides the user throughout the biopsv work-flow. The hardware components enable the use of a variety of off-the-shelf biopsy vacuum needles. In addition to the hardware components, the biopsy system accessory includes software components which, in part, through the user interface help quide the user stepwise through the biopsy workflow. The Discovery NM 750b Biopsy system is designed to support a variety of commercially available vacuum assisted biopsy devices and needles.

Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel. Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used intraoperatively if a protective sheath is used. Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Sentinella 102 is a currently marketed portable gamma camera system which includes a small gamma camera designed to obtain images from small organs and structures labeled using radionuclides emitting gamma-rays. The Sentinella system also includes analysis and display equipment, a cart and ergonomic arm, which facilitates the equipment portability and positioning, and accessories. Due to the difficulty which may involve indentifying the physical location in the body of the patient of the structures observed in the gammagraphy, the model Sentinella 102 Horus incorporates an optical camera that registers the same area that it is being observed by the gamma camera. Both images are coregistered and shown in real time. During this process, the gammagraphy is not reprocessed or modified in any way, so remains unaltered at the end of the process.

Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel. Sentinella 102 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used. Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection.

The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies. It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.

The ergo Imaging System incorporates Digirad's Solid State RIM detector design with 3mm pixels for general purpose planar imaging, cleared under K100838. Sterile drapes are specified for intraoperative use. The ergo Imaging System, in conjunction with the optional Breast Imaging Accessory (BIA), enables the user to perform scintimammography and extremity imaging with stabilization.

The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM™ Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.

The LumaGEM™ Molecular Breast Imaging System is a scintillation camera system, which uses Cadmium Zinc Telluride (CZT) detectors to create an image of radionuclide distribution. The LumaGEM™ Molecular Breast Imaging System is available in a dualhead or single-head configuration and can be used to help identify suspected lesions in breast tissue as an adjunct to standard mammography. The LumaGEM™ Molecular Breast Imaging System is provided with a customized gantry, which allows flexible positioning to facilitate accurate breast imaging, and a workstation to enable image acquisition and analysis functions.

The Dilon 6800 Acella Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.

The Dilon 6800 Acella (Acella) is a modification to the Dilon 2000 (now known as the Dilon 6800), a high resolution, small field of view, portable gamma camera designed for general use in imaging radio pharmaceuticals. The Acella has a larger field-of-view than the Dilon 6800 and replaces photomultiplier tubes with photodiodes. Both technologies convert visible light photons generated by scintillation crystals into electronic signals.