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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
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution
- B052QCTPROM4ASH0 ()
- QCTPROM4ASHN0100 ()
- QCTPROM4ASHN0075 ()
- QCTPROM4ASHN0050 ()
- QCTPROM4ASHN0025 ()
- QCTPROM4ASHN0010 ()
- QCTPROM4ASHN0005 ()
- QCTPROM4ASHN0003 ()
- QCTPROM4ASHN0002 ()
- QCTPROM4ASHN0500 ()
- QCTPROM4ASHN0200 ()
QCTPROM4ASH
- 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
- CTXA Hip Bone Mineral Densitometer
- CTXA Hip Extended Reference Database
MINDWAYS SOFTWARE, INC.
K894854K002113K030330
In Commercial Distribution
- B052QCTPROM0SSH0 ()
QCTPROM0SSH
- 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
Convenience Kit consisting of
- QCT Pro Asynchronous Calibration Module, CliniQCT
- QCT Bone Mineral Density Analysis Software
- Accessories
MINDWAYS SOFTWARE, INC.
K894854K140342
In Commercial Distribution
- B052QCTPROM0AS0 ()
QCTPROM0AS
- CT system application software
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.
MINDWAYS SOFTWARE, INC.
K894854
In Commercial Distribution
- B052DIQCTPRO0 ()
DI_QCTPRO
- 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
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
P700M A/C
In Commercial Distribution
- B216P700MAC1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
MB-715NT
In Commercial Distribution
- B216MB715NT1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
LB-715NT
In Commercial Distribution
- B216LB715NT1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV
ARQUILLA, INC.
HF 718BD
In Commercial Distribution
- B216HF718BD1 ()
- Stationary basic diagnostic x-ray system, analogue
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
HDRI-715A-40
In Commercial Distribution
- B216HDRI715A401 ()
- Stationary basic diagnostic x-ray system, analogue
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
HDR-715A-40
In Commercial Distribution
- B216HDR715A401 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 10mA, 50-90kV
ARQUILLA, INC.
FB910A-40K
In Commercial Distribution
- B216FB910A40K1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
FB-715NT
In Commercial Distribution
- B216FB715NT1 ()
- Stationary basic diagnostic x-ray system, analogue
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
DRH-700 A/C
In Commercial Distribution
- B216DRH700AC1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
BDXC-700
In Commercial Distribution
- B216BDXC7001 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715T-BD
In Commercial Distribution
- B216715TBD1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715-SD
In Commercial Distribution
- B216715SD1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715R-SD
In Commercial Distribution
- B216715RSD1 ()
- Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715B-BD
In Commercial Distribution
- B216715BBD1 ()
- Stationary basic diagnostic x-ray system, analogue
TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
medimaps group SA
4.0
In Commercial Distribution
- B214OSTBSIV400 ()
- Basic diagnostic x-ray system application software
No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution
- 07630016841552 ()
- Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution
- 07630016817137 ()
- Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
AB-6500
Not in Commercial Distribution
- 07630016809705 ()
- Hearing implant implantable-component tester, postoperative
LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution
- 60889971029881 ()
1029883
- Basic diagnostic x-ray system application software
LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM DENTAL LLC
Logicon Caries Detector
Not in Commercial Distribution
- 60192156851628 ()
8008690
- General-purpose dental x-ray system application software
LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM HEALTH, INC.
Logicon Caries Detector
In Commercial Distribution
- 60889978008698 ()
8008690
- General-purpose dental x-ray system application software
CS 3D IMAGING
CARESTREAM HEALTH, INC.
CS 3D Imaging Software
In Commercial Distribution
- 60889975319582 ()
5319587
- General-purpose dental x-ray system application software
DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution
- 60889975319575 ()
5319579
- General-purpose dental x-ray system application software