Other products from "NORLAND AT SWISSRAY"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00866955000492 uREzpocus L Linear probe. IYN System, Imaging, Pulsed Doppler, Ultrasonic 2 uREzpocus
2 00866955000485 uREzpocus C Convex probe. IYN System, Imaging, Pulsed Doppler, Ultrasonic 2 uREzpocus
3 00860008461223 uREzpocus M Ultrasonic pulsed doppler imaging system - MicroConvex array IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 uREzpocus
4 00860008461216 uREzpocus H Ultrasonic pulsed doppler imaging system - uREzpocus H IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 uREzpocus
5 00860008461209 uREzpocus C-EMS Ultrasonic pulsed doppler imaging system - Convex HD array IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 uREzpocus
6 00866955000416 600 XR-600 Clinical Bone Desitometer KGI Densitometer, Bone 2 XR-600 Clinical
7 00866955000461 Elite Elite Bone Densitometer KGI Densitometer, Bone 2 Elite
8 00866955000423 600 XR-600 Advanced KGI Densitometer, Bone 2 XR-600 Advanced
9 00866955000454 800 XR-800 Advanced Bone Densitometer KGI Densitometer, Bone 2 XR-800 Advanced
10 00866955000447 800 XR- 800 Clinical Bone Densitometer KGI Densitometer, Bone 2 XR- 800 Clinical
11 00866955000430 800 XR-800 Basic Bone Densitometer KGI Densitometer, Bone 2 XR-800 Basic
12 00866955000409 600 XR-600 Basic Bone Densitometer KGI Densitometer, Bone 2 XR-600 Basic
Other products with the same Product Code "KGI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00866955000478 4 IlluminatusDXA Software NORLAND AT SWISSRAY
2 00866955000461 Elite Elite Bone Densitometer Elite NORLAND AT SWISSRAY
3 00866955000454 800 XR-800 Advanced Bone Densitometer XR-800 Advanced NORLAND AT SWISSRAY
4 00866955000447 800 XR- 800 Clinical Bone Densitometer XR- 800 Clinical NORLAND AT SWISSRAY
5 00866955000430 800 XR-800 Basic Bone Densitometer XR-800 Basic NORLAND AT SWISSRAY
6 00866955000423 600 XR-600 Advanced XR-600 Advanced NORLAND AT SWISSRAY
7 00866955000416 600 XR-600 Clinical Bone Desitometer XR-600 Clinical NORLAND AT SWISSRAY
8 00866955000409 600 XR-600 Basic Bone Densitometer XR-600 Basic NORLAND AT SWISSRAY
9 00860000233101 A VirtuOst uses data from computed tomography scans to estimate bone mineral densi VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation. VirtuOst O N DIAGNOSTICS LLC
10 00840682138352 C2 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
11 00840682138345 F2 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
12 00840682117142 C1 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
13 00840682117098 F1 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
14 00840682117029 F1 Lunar iDXA GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
15 B214OSTBSI3120 3.1.2 TBS iNsight is a software provided for use as a complement to both DXA analysis TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. TBS iNsight MED-IMAPS
16 B214OSTBSI3110 3.1.1 TBS iNsight is a software provided for use as a complement to both DXA analysis TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. TBS iNsight MED-IMAPS
17 B214OSTBSI3100 3.1.0 TBS iNsight is a software provided for use as a complement to both DXA analysis TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. TBS iNsight MED-IMAPS
18 B214OSTBSI303 3.0.3.0 TBS iNsight is a software provided for use as a complement to both DXA analysis TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. TBS iNsight MED-IMAPS
19 B214OSTBSI30 3.0.2.0 TBS iNsight is a software provided for use as a complement to both DXA analysis TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. TBS iNsight MED-IMAPS
20 B214OSTBSI0 3.0.1.0 TBS iNsight is a software provided for use as a complement to both DXA analysis TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. Medimaps TBS iNsight MED-IMAPS
21 B052QCTPROM4ASH0 K894854K002113K030330K140342 QCTPROM4ASH Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT- QCT Bone Mineral Density Analysis Software- CTXA Hip Bone Mineral Densitometer- CTXA Hip Extended Reference Database- Model 4 Calibration Phantom QCT PRO Asynchronous 3D Spine and CTXA-Hip System MINDWAYS SOFTWARE, INC.
22 B052QCTPROM3SSH0 K894854K002113K030330 QCTPROM3SSH Convenience Kit consisting of- QCT Bone Mineral Density Analysis Software- CTXA Convenience Kit consisting of- QCT Bone Mineral Density Analysis Software- CTXA Hip Bone Mineral Densitometer- CTXA Hip Extended Reference Database- Model 3 QA & Calibration Phantom Set QCT PRO 3D Volumetric Spine and CTXA Hip System MINDWAYS SOFTWARE, INC.
23 B052QCTPROM3SS0 K894854 QCTPROM3SS Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software,- Mod Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software,- Model 3 QA & Calibration Phantom Set and- Accessories. QCT PRO 3D Volumetric Spine System MINDWAYS SOFTWARE, INC.
24 B052QCTPROM3ASH0 K894854K002113K030330K140342 QCTPROM3ASH Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT- QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set QCT PRO Asynchronous 3D Spine and CTXA-Hip System MINDWAYS SOFTWARE, INC.
25 B052QCTPROM0SSH0 K894854K002113K030330 QCTPROM0SSH Convenience Kit consisting of- QCT Bone Mineral Density Analysis Software- CTXA Convenience Kit consisting of- QCT Bone Mineral Density Analysis Software- CTXA Hip Bone Mineral Densitometer- CTXA Hip Extended Reference Database QCT PRO 3D Volumetric Spine and CTXA Hip Software MINDWAYS SOFTWARE, INC.
26 B052QCTPROM0SS0 K894854 QCTPROM0SS Convenience Kit consisting of- QCT Bone Mineral Density Analysis Software- Accessories QCT PRO 3D Volumetric Spine Software MINDWAYS SOFTWARE, INC.
27 B052QCTPROM0ASH0 K894854K002113K030330K140342 QCTPROM0ASH Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT- QCT Bone Mineral Density Analysis Software- CTXA Hip Bone Mineral Densitometer- CTXA Hip Extended Reference Database QCT PRO Asynchronous 3D Spine and CTXA-Hip Software MINDWAYS SOFTWARE, INC.
28 B052QCTPROM0AS0 K894854K140342 QCTPROM0AS Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT- QCT Bone Mineral Density Analysis Software- Accessories QCT PRO Asynchronous 3D Spine Software MINDWAYS SOFTWARE, INC.
29 B052DIQCTPRO0 K894854 DI_QCTPRO The method of Quantitative Computed Tomography (QCT) has been established as a m The method of Quantitative Computed Tomography (QCT) has been established as a means of non-invasive quantitative bone mineral determination. The QCT PRO software system allows to map information obtained from executing protocols with commercially available CT scanners to an estimate of bone mineral content. The QCT PRO software system does not interfere directly with a medical device. Its function is to provide a means of entering, storing and obtaining information/data only. A competent health professional is reasonably expected to exercise judgement in the use of the information provided by the system. The QCT PRO software system provides a means of entering or receiving general patient information including age and gender, and information on the CT scanning parameters used in performing the CT scanning protocol. Hounsfield numbers from regions of interest (ROI) of the CT data are processed to provide an estimate of bone mineral density (BMD) for each region of interest (ROI) for which Hounsfield numbers were obtained. QCT Bone Mineral Density Analysis Software MINDWAYS SOFTWARE, INC.
30 B052DICTXAHIPEXTDB0 K030330 DI_CTXAHIPEXTDB The CTXA Hip Extended Reference Data is an accessory to the CTXA Hip Bone Minera The CTXA Hip Extended Reference Data is an accessory to the CTXA Hip Bone Mineral Densitometer. The CTXA Hip Extended Reference Data is used within the CTXA Hip module to calculate T-scores and percent young normal for any patient, and Z-scores for patients age 20-80 for BMD estimates made using the CTXCA Hip module. TThe intended use of the CTXA Hip Extended Reference Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician.The predicate K002113 CTXA Hip Bone Mineral Densitometer Module (CTXA Hip) provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from DXA devices. These BMD estimates from the predicate device are compared to a reference database of age 20-39 US Caucasian females to calculate T-scores and percent young normal for patient BMD estimates and Z-scores for patient BMD estimates for ages 20-39. The current CTXA Hip Extended Reference Data is an accessory to CTXA Hip that also is used to calculate T-scores and percent young normal, and also is used to calculate Z-scores for ages 20-80. The CTXA Hip BMD estimates referenced to the CTXA Hip Extended Reference Data reference population are used as an aid to the physician in identifying patients with low bone mineral density and as an aid in determining a patient's fracture risk. BMD estimates obtained with CTXA Hip with Extended Reference Data accessory are identical to BMD estimates obtained with the predicate CTXA Hip. T-scores calculated with CTXA Hip with Extended Refecrence Data accessory are slightly less negative or less positive than those calculated with CTXA Hip,approximately 0.1-0.2 T-score units. CTXA Hip Extended Reference Data MINDWAYS SOFTWARE, INC.
31 B052DICTXAHIP0 K002113 DI_CTXAHIP The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), in grams, and bone mineral density (BMD), in g/cm2, of the proximal femur. The CTXA Hip uses quantitative computed tomography (QCT) methods to derive bone mass and bone density estimates from 3D CT image data sets obtained from compatible, whole-body CT scanners and with compatible CT calibration phantoms. BMD estimates are derived in units of g/cm2 equivalent K2HPO4 density. The BMD estimates can be compared with CTCA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores ca be used by the physician an an aid in determining fracture risk.CTXA Hip uses the same technical procedures to acquire and calibrate CT image data as are used for the predicate device K894854: QCT Bone Mineral Density Analysis Software. CTXA Hip reference data for young normal US Caucasian females were acquired in a clinical study, so that patient results obtained using CTXA Hip can be compared to this normal reference population. The CTXA Hip BMD estimates compared to the CTXA Hip reference population are sued as an aid to the physician in identifying patients with low bone mineral density. Additionally, normal data comparisons provide a basis for estimating fracture risk.BMC and BMD estimates are returned by the CTXA Hip for the following proximal femur regions of interest (ROIs): (1) femoral neck, (2) trochanter, (3) intertrochanter, (4) Ward’s triangle, and (5) total hip (i.e., superposition of ROIs 1-3). CTXA Hip Bone Mineral Densitometer MINDWAYS SOFTWARE, INC.
32 B052DIASYNC0 K140342 DI_ASYNC The QCT Pro Asynchronous Calibration Module is intended to provide an alternativ The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedureinvolving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure. QCT Pro Asynchronous Calibration Module, CliniQCT MINDWAYS SOFTWARE, INC.
33 15420045507494 APEX Practice Managment Tool APEX Practice Managment Tool HOLOGIC, INC.
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35 15420045506909 Discovery C Discovey C HOLOGIC, INC.
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37 15420045506879 Discovery A Discovery A HOLOGIC, INC.
38 15420045505889 Discovery Wi Discovery Wi HOLOGIC, INC.
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41 15420045505834 Horizon W Horizon W HOLOGIC, INC.
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43 15420045505698 Horizon C Horizon C HOLOGIC, INC.
44 15420045505384 Horizon A Horizon A HOLOGIC, INC.
45 04260491560025 XCT 3000 XCT 3000 Peripheral quantitative computed tomograph for the measurement at femur, radius Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography. NA STRATEC MEDIZINTECHNIK GMBH
46 04260491560018 XCT 2000L XCT 2000L Peripheral quantitative computed tomograph for the measurement at femur, radius Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography. NA STRATEC MEDIZINTECHNIK GMBH