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WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.2
In Commercial Distribution
- B148WSONE1820 ()
- Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.1
In Commercial Distribution
- B148WSONE1810 ()
- Radiology picture archiving and communication system workstation
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 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
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution
- B052QCTPROM3ASH0 ()
QCTPROM3ASH
- 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 Pro Asynchronous Calibration Module, CliniQCT
- QCT Bone Mineral Density Analysis Software
- CTXA Hip Bone Mineral Densitometer
- CTXA Hip Extended Reference Database
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution
- B052QCTPROM0ASH0 ()
QCTPROM0ASH
- 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
Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution
- B052PHCTM40 ()
- Bone densitometry x-ray phantom, test object
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 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