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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
- 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
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 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
- 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 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
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
1.9.3
In Commercial Distribution
- B148WSONE1930 ()
- 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
1.9.2
In Commercial Distribution
- B148WSONE1920 ()
- 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
1.9.1
In Commercial Distribution
- B148WSONE1910 ()
- 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
1.9.0
In Commercial Distribution
- B148WSONE1900 ()
- 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
1.8.9
In Commercial Distribution
- B148WSONE1890 ()
- 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
1.8.8
In Commercial Distribution
- B148WSONE1880 ()
- 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
1.8.7
In Commercial Distribution
- B148WSONE1870 ()
- 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
1.8.6
In Commercial Distribution
- B148WSONE1860 ()
- 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
1.8.5
In Commercial Distribution
- B148WSONE1850 ()
- 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
1.8.4
In Commercial Distribution
- B148WSONE1840 ()
- 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
1.8.3
In Commercial Distribution
- B148WSONE1830 ()
- 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
1.8.2
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
A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.4.70
In Commercial Distribution
- 00850009343321 ()
- Radiological PACS software
Long Drill
A.B. DENTAL DEVICES LTD
TDL-4.2
In Commercial Distribution
- 17290111274746 ()
- 07290111274749 ()
TDL-4.2
- Fixture/appliance dental drill bit, reusable
Long Drill
A.B. DENTAL DEVICES LTD
TDL-3.65
In Commercial Distribution
- 17290111274739 ()
- 07290111274732 ()
TDL-3.65
- Fixture/appliance dental drill bit, reusable
Long Drill
A.B. DENTAL DEVICES LTD
TDL-3.2
In Commercial Distribution
- 17290111274722 ()
- 07290111274725 ()
TDL-3.2
- Fixture/appliance dental drill bit, reusable
Long Drill
A.B. DENTAL DEVICES LTD
TDL-2.8
In Commercial Distribution
- 17290111274715 ()
- 07290111274718 ()
TDL-2.8
- Fixture/appliance dental drill bit, reusable
Long Drill
A.B. DENTAL DEVICES LTD
TDL-2.5
In Commercial Distribution
- 17290111274708 ()
- 07290111274701 ()
TDL-2.5
- Fixture/appliance dental drill bit, reusable
Coated Drill Bit
A.B. DENTAL DEVICES LTD
TDD-4.0
In Commercial Distribution
- 17290111274647 ()
- 07290111274640 ()
TDD-4.0
- Fixture/appliance dental drill bit, reusable
Coated Drill Bit
A.B. DENTAL DEVICES LTD
TDD-3.65
In Commercial Distribution
- 17290111274630 ()
- 07290111274633 ()
TDD-3.65
- Fixture/appliance dental drill bit, reusable
Coated Drill Bit
A.B. DENTAL DEVICES LTD
TDD-3.2
In Commercial Distribution
- 17290111274623 ()
- 07290111274626 ()
TDD-3.2
- Fixture/appliance dental drill bit, reusable
Coated Drill Bit
A.B. DENTAL DEVICES LTD
TDD-2.8
In Commercial Distribution
- 17290111274616 ()
- 07290111274619 ()
TDD-2.8
- Fixture/appliance dental drill bit, reusable
Coated Drill Bit
A.B. DENTAL DEVICES LTD
TDD-2.5
In Commercial Distribution
- 17290111274609 ()
- 07290111274602 ()
TDD-2.5
- Fixture/appliance dental drill bit, reusable
Conical Drill Bit
A.B. DENTAL DEVICES LTD
TDC-5.0
In Commercial Distribution
- 17290111274586 ()
- 07290111274589 ()
TDC-5.0
- Fixture/appliance dental drill bit, reusable
Conical Drill Bit
A.B. DENTAL DEVICES LTD
TDC-4.2
In Commercial Distribution
- 17290111274579 ()
- 07290111274572 ()
TDC-4.2
- Fixture/appliance dental drill bit, reusable
Drill Bit
A.B. DENTAL DEVICES LTD
TD-5.2
In Commercial Distribution
- 07290111274565 ()
- 17290111274562 ()
TD-5.2
- Fixture/appliance dental drill bit, reusable
Drill Bit
A.B. DENTAL DEVICES LTD
TD-4.2
In Commercial Distribution
- 17290111274555 ()
- 07290111274558 ()
TD-4.2
- Fixture/appliance dental drill bit, reusable
Drill Bit
A.B. DENTAL DEVICES LTD
TD-3.8
In Commercial Distribution
- 17290111274548 ()
- 07290111274541 ()
TD-3.8
- Fixture/appliance dental drill bit, reusable
Drill Bit, 2.8 mm Diameter
A.B. DENTAL DEVICES LTD
TD-2.8
In Commercial Distribution
- 07290111274534 ()
TD-2.8
- Fixture/appliance dental drill bit, reusable
Drill Bit, 2.5 mm Diameter
A.B. DENTAL DEVICES LTD
TD-2.5
In Commercial Distribution
- 07290111274527 ()
TD-2.5
- Fixture/appliance dental drill bit, reusable
Drill Bit
A.B. DENTAL DEVICES LTD
TD-1.5
In Commercial Distribution
- 17290111274517 ()
- 07290111274510 ()
TD-1.5
- Fixture/appliance dental drill bit, reusable
Drill Bit
A.B. DENTAL DEVICES LTD
TD-1.2
In Commercial Distribution
- 17290111274500 ()
- 07290111274503 ()
TD-1.2
- Fixture/appliance dental drill bit, reusable
Ratchet Hex Driver for I6B
A.B. DENTAL DEVICES LTD
T3-I6B-S
In Commercial Distribution
- 17290111274425 ()
- 07290111274428 ()
T3-I6B-S
- Surgical screwdriver, reusable
Ratchet Hex Driver for I6B
A.B. DENTAL DEVICES LTD
T3-I6B-L
In Commercial Distribution
- 17290111274418 ()
- 07290111274411 ()
T3-I6B-L
- Surgical screwdriver, reusable
Ratchet Hex Driver for I6B
A.B. DENTAL DEVICES LTD
T3-I6B-18
In Commercial Distribution
- 17290111274401 ()
- 07290111274404 ()
T3-I6B-18
- Surgical screwdriver, reusable
Driver for installing the implant through AB Guide
A.B. DENTAL DEVICES LTD
T3G-2.4,30-G
In Commercial Distribution
- 17290111274395 ()
- 07290111274398 ()
T3G-2.4,30-G
- Surgical screwdriver, reusable