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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.
MINDWAYS SOFTWARE, INC.
K030330
In Commercial Distribution
- B052DICTXAHIPEXTDB0 ()
DI_CTXAHIPEXTDB
- CT system application software
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).
MINDWAYS SOFTWARE, INC.
K002113
In Commercial Distribution
- B052DICTXAHIP0 ()
DI_CTXAHIP
- CT system application software
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 procedure
involving 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.
MINDWAYS SOFTWARE, INC.
K140342
In Commercial Distribution
- B052DIASYNC0 ()
DI_ASYNC
- CT system application software
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
MINDWAYS SOFTWARE, INC.
K894854K002113K030330
In Commercial Distribution
- B052QCTPROM3SSH0 ()
QCTPROM3SSH
- CT system application software
Convenience Kit consisting of
- QCT Bone Mineral Density Analysis Software,
- Model 3 QA & Calibration Phantom Set and
- Accessories.
MINDWAYS SOFTWARE, INC.
K894854
In Commercial Distribution
- B052QCTPROM3SS0 ()
QCTPROM3SS
- CT system application software
Convenience Kit consisting of
- QCT Bone Mineral Density Analysis Software
- Accessories
MINDWAYS SOFTWARE, INC.
K894854
In Commercial Distribution
- B052QCTPROM0SS0 ()
QCTPROM0SS
- CT system application software
Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution
- 04030685900001 ()
- 04030685900018 ()
- No size - Software as a Medical Device
N/A
- Clinical management support software
The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution
- 00862290000326 ()
- Cognitive assessment software
No Description
FIM MEDICAL
Software
In Commercial Distribution
- 03760253450577 ()
- Pulmonary function analysis system, adult
No Description
FIM MEDICAL
Software
Not in Commercial Distribution
- 03760253450157 ()
- Pulmonary function analysis system, adult
No Description
Fujirebio Europe
15687
In Commercial Distribution
- 05414470156870 ()
- Laboratory instrument/analyser application software IVD
Software
AGFA
2.0
In Commercial Distribution
- 05414904271124 ()
E5C34
- Radiological PACS software
Software
DEXIS LLC
11
In Commercial Distribution
- EKAV101244750 ()
1.012.4475
- Radiology information system application software
Software
DEXIS LLC
11
In Commercial Distribution
- EKAV101135330 ()
10124479
- Radiology information system application software
Software
CAPSOVISION, INC.
3
In Commercial Distribution
- 00867770000216 ()
2759
- Video capsule endoscopy system application software
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Fujirebio Diagnostics, Inc.
CL0012
In Commercial Distribution
- 00869164000048 ()
- Laboratory instrument/analyser application software IVD
Software
PRECISION BIOMETRICS INC
Feature Pack H
In Commercial Distribution
- 00853818007477 ()
- Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack G
In Commercial Distribution
- 00853818007392 ()
- Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack E
In Commercial Distribution
- 00853818007101 ()
- Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack D
In Commercial Distribution
- 00853818007095 ()
- Bioelectrical signal analysis software