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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
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
Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution
- 60889971045072 ()
1045079
- General-purpose dental x-ray system application software
CS IMAGING V7 update only
CARESTREAM HEALTH, INC.
CS Imaging Software V7
Not in Commercial Distribution
- 60889971745927 ()
1745926
- General-purpose dental 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
CS IMAGING CLIENT SERVER SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
Not in Commercial Distribution
- 60192155943010 ()
5943014
- General-purpose dental x-ray system application software
CSD LOGICON CARIES DETECTOR
CARESTREAM DENTAL LLC
Logicon Caries Detector
In Commercial Distribution
- 60192155942754 ()
5942750
- General-purpose dental x-ray system application software
Trophy Imaging 8
CARESTREAM DENTAL LLC
Trophy Imaging 8
In Commercial Distribution
- 60192155500688 ()
5500681
- General-purpose dental x-ray system application software
CS IMAGING 8 SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution
- 60192155500671 ()
5500673
- General-purpose dental x-ray system application software
CS 3D IMAGING
CARESTREAM DENTAL LLC
CS 3D Imaging Software
In Commercial Distribution
- 60192155319587 ()
5319587
- General-purpose dental x-ray system application software
DENTAL IMAGING SOFTWARE
CARESTREAM DENTAL LLC
Dental Imaging Software
In Commercial Distribution
- 60192155319570 ()
5319579
- General-purpose dental x-ray system application software
TROPHY 3D IMAGING
CARESTREAM DENTAL LLC
Trophy 3D Imaging
In Commercial Distribution
- 60192155319556 ()
5319553
- General-purpose dental x-ray system application software
CS Imaging Suite
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution
- 60192155314308 ()
5314307
- 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 IMAGING V7 WINDOWS EDITION
CARESTREAM HEALTH, INC.
CS Imaging Suite
In Commercial Distribution
- 60889975314303 ()
5314307
- General-purpose dental x-ray system application software
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
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
No Description
QUALITY ELECTRODYNAMICS LLC
2001001
In Commercial Distribution
- 00814848020232 ()
MAC000112
- Radiation therapy simulation system
No Description
QUALITY ELECTRODYNAMICS LLC
2001000
In Commercial Distribution
- 00814848020218 ()
MAC000111
- Radiation therapy simulation system
The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution
- 00810030350002 ()
- Stationary basic diagnostic x-ray system, analogue
NobelClinician 3.1 for MAC
Nobel Biocare AB
3.1
Not in Commercial Distribution
- 07332747125177 ()
101560
- General-purpose dental x-ray system application software
NobelClinician 3.1 for Windows 64-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution
- 07332747125160 ()
101560
- General-purpose dental x-ray system application software