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The Brewer LiftMate Patient Lift is used in examination rooms for safely lifting patients with mobility issues onto exam tables.
The Brewer Company LLC
3000
Not in Commercial Distribution
- 00728564000006 ()
3000
- Freestanding patient lifting system, electrically-powered
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
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
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 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