| 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 | 00840682117029 | F1 | KGI | Densitometer, bone | 2 | Lunar iDXA | ||
| 8 | 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 | |
| 9 | 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 | |
| 10 | 00840682141161 | ABUS 2.0 | PAA | Automated breast ultrasound | 3 | Invenia | ||
| 11 | 00840682141109 | ABUS Viewer | LLZ | System, image processing, radiological | 2 | Invenia | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 00840682100090 | ABUS Review Software | PAA | Automated breast ultrasound | 3 | Invenia | ||
| 22 | 00840682100038 | ABUS Workstation | H5014WS | PAA | Automated Breast Ultrasound | 3 | Invenia | |
| 23 | 00840682100021 | ABUS Scan Station | H5014SS | PAA | Automated Breast Ultrasound | 3 | Invenia | |
| 24 | 00840682100014 | ABUS System | H5014PM | PAA | Automated Breast Ultrasound | 3 | Invenia | |
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 00840682138352 | C2 | KGI | Densitometer, bone | 2 | Prodigy | ||
| 28 | 00840682138345 | F2 | KGI | Densitometer, bone | 2 | Prodigy | ||
| 29 | 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 | |
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 00840682117142 | C1 | 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 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 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 | |
| 3 | 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 | |
| 4 | 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 | |
| 5 | 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 | |
| 6 | 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 | |
| 7 | 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. |
| 8 | 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. |
| 9 | 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. |
| 10 | 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. |
| 11 | 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. |
| 12 | B052QCTPROM0SS0 | K894854 | QCTPROM0SS | Convenience Kit consisting of- QCT Bone Mineral Density Analysis Software- Accessories | QCT PRO 3D Volumetric Spine Software | MINDWAYS SOFTWARE, INC. |
| 13 | 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. |
| 14 | 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. |
| 15 | 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. |
| 16 | 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. |
| 17 | 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. |
| 18 | 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. |
| 19 | 15420045507494 | APEX Practice Managment Tool | APEX Practice Managment Tool | HOLOGIC, INC. | ||
| 20 | 15420045506916 | Discovery W | Discovery W | HOLOGIC, INC. | ||
| 21 | 15420045506909 | Discovery C | Discovey C | HOLOGIC, INC. | ||
| 22 | 15420045506893 | Discovery SL | Discovery SL | HOLOGIC, INC. | ||
| 23 | 15420045506879 | Discovery A | Discovery A | HOLOGIC, INC. | ||
| 24 | 15420045505889 | Discovery Wi | Discovery Wi | HOLOGIC, INC. | ||
| 25 | 15420045505872 | Discovery Ci | Discovery Ci | HOLOGIC, INC. | ||
| 26 | 15420045505865 | Horizon Wi | Horizon Wi | HOLOGIC, INC. | ||
| 27 | 15420045505834 | Horizon W | Horizon W | HOLOGIC, INC. | ||
| 28 | 15420045505827 | Horizon Ci | Horizon Ci | HOLOGIC, INC. | ||
| 29 | 15420045505698 | Horizon C | Horizon C | HOLOGIC, INC. | ||
| 30 | 15420045505384 | Horizon A | Horizon A | HOLOGIC, INC. | ||
| 31 | 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 |
| 32 | 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 |
| 33 | 00866955000478 | 4 | IlluminatusDXA Software | NORLAND AT SWISSRAY | ||
| 34 | 00866955000461 | Elite | Elite Bone Densitometer | Elite | NORLAND AT SWISSRAY | |
| 35 | 00866955000454 | 800 | XR-800 Advanced Bone Densitometer | XR-800 Advanced | NORLAND AT SWISSRAY | |
| 36 | 00866955000447 | 800 | XR- 800 Clinical Bone Densitometer | XR- 800 Clinical | NORLAND AT SWISSRAY | |
| 37 | 00866955000430 | 800 | XR-800 Basic Bone Densitometer | XR-800 Basic | NORLAND AT SWISSRAY | |
| 38 | 00866955000423 | 600 | XR-600 Advanced | XR-600 Advanced | NORLAND AT SWISSRAY | |
| 39 | 00866955000416 | 600 | XR-600 Clinical Bone Desitometer | XR-600 Clinical | NORLAND AT SWISSRAY | |
| 40 | 00866955000409 | 600 | XR-600 Basic Bone Densitometer | XR-600 Basic | NORLAND AT SWISSRAY | |
| 41 | 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 | |
| 42 | 00840682138352 | C2 | Prodigy | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC | ||
| 43 | 00840682138345 | F2 | Prodigy | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC | ||
| 44 | 00840682117142 | C1 | Prodigy | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC | ||
| 45 | 00840682117098 | F1 | Prodigy | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC | ||
| 46 | 00840682117029 | F1 | Lunar iDXA | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC |