Other products from "GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00840682138840 R2 ITX,IYO,IYN Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic 2 Venue Go
2 00840682143165 S4-10 ITX Transducer, ultrasonic, diagnostic 2 NA
3 00840682190503 R3 Venue Go R3 Final Assembly ITX,IYO,IYN Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic 2 Venue Go
4 00840682104951 S4-10-D IYO,ITX,IYN System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic 2 NA
5 00195278516541 R4 UPG Venue Go R4 MD either eDelivery or physical ITX,IYO,IYN Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic 2 Venue Go
6 00195278516510 R4 Venue Go R4 Final Assembly 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 Venue Go
7 00195278005861 R3 UPG Venue Go R3 MD eDelivery or Physical Upgrade IYN,ITX,IYO System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic 2 Venue GO
8 00195278384041 E10 R3 LOGIQ E10 R3 Console ITX,IYO,IYN Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic 2 LOGIQ
9 00840682141161 ABUS 2.0 PAA Automated breast ultrasound 3 Invenia
10 00840682141109 ABUS Viewer LLZ System, image processing, radiological 2 Invenia
11 00840682102377 E9 IYO,ITX,IYN System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic 2 LOGIQ
12 00840682147118 E10 R1 to R2 UPG IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 LOGIQ
13 00840682145640 E10 R2 ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 LOGIQ
14 00840682138260 E10 IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 LOGIQ
15 00840682120173 E9 R3 to R4 UPG ITX,IYO,IYN Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic 2 LOGIQ
16 00840682120159 E9 R4 to R5 UPG IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 LOGIQ
17 00840682102421 E9 R3 to XDclear 2.0 UPG IYN,ITX,IYO System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic 2 LOGIQ
18 00840682102414 E9 R5 to XDclear 2.0 UPG IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 LOGIQ
19 00840682102407 E9 R4 to XDclear 2.0 UPG IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 LOGIQ
20 00840682100090 ABUS Review Software PAA Automated breast ultrasound 3 Invenia
21 00840682100038 ABUS Workstation H5014WS PAA Automated Breast Ultrasound 3 Invenia
22 00840682100021 ABUS Scan Station H5014SS PAA Automated Breast Ultrasound 3 Invenia
23 00840682100014 ABUS System H5014PM PAA Automated Breast Ultrasound 3 Invenia
24 00840682139212 R2 UPG 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 Venue
25 00840682138888 R2 IYN,ITX,IYO System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic 2 Venue
26 00840682138352 C2 KGI Densitometer, bone 2 Prodigy
27 00840682138345 F2 KGI Densitometer, bone 2 Prodigy
28 00840682190510 R3 Venue R3 final Assembly IYO,ITX,IYN System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic 2 Venue
29 00840682124324 5205000-8 IYN,ITX,IYO System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic 2 LOGIQ E9
30 00840682123815 R1 IYO,ITX,IYN System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic 2 Venue
31 00840682117142 C1 KGI Densitometer, bone 2 Prodigy
32 00840682117098 F1 KGI Densitometer, bone 2 Prodigy
33 00195278516534 R4 UPG Venue R4 MD either eDelivery or physical ITX,IYO,IYN Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic 2 Venue
34 00195278516480 R4 Venue R4 final Assembly 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 Venue
35 00195278005830 R3 UPG Venue R3 MD eDelivery or Physical Upgrade IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 Venue
36 00195278516497 R4 Venue Fit R4 Final Assembly IYO,ITX,IYN System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic 2 Venue Fit
37 00195278513014 R4 UPG Venue Fit R4 MD either eDelivery or physical ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 Venue Fit
38 00195278194275 R3 Venue Fit final Assy. IYN,ITX,IYO System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic 2 Venue Fit
Other products with the same Product Code "KGI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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
2 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
3 00866955000478 4 IlluminatusDXA Software NORLAND AT SWISSRAY
4 00866955000461 Elite Elite Bone Densitometer Elite NORLAND AT SWISSRAY
5 00866955000454 800 XR-800 Advanced Bone Densitometer XR-800 Advanced NORLAND AT SWISSRAY
6 00866955000447 800 XR- 800 Clinical Bone Densitometer XR- 800 Clinical NORLAND AT SWISSRAY
7 00866955000430 800 XR-800 Basic Bone Densitometer XR-800 Basic NORLAND AT SWISSRAY
8 00866955000423 600 XR-600 Advanced XR-600 Advanced NORLAND AT SWISSRAY
9 00866955000416 600 XR-600 Clinical Bone Desitometer XR-600 Clinical NORLAND AT SWISSRAY
10 00866955000409 600 XR-600 Basic Bone Densitometer XR-600 Basic NORLAND AT SWISSRAY
11 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
12 00840682138352 C2 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
13 00840682138345 F2 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
14 00840682117142 C1 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
15 00840682117098 F1 Prodigy GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
16 00840682117029 F1 Lunar iDXA GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
17 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
18 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
19 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
20 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
21 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
22 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
23 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.
24 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.
25 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.
26 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.
27 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.
28 B052QCTPROM0SS0 K894854 QCTPROM0SS Convenience Kit consisting of- QCT Bone Mineral Density Analysis Software- Accessories QCT PRO 3D Volumetric Spine Software MINDWAYS SOFTWARE, INC.
29 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.
30 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.
31 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.
32 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.
33 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.
34 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.
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