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The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller.
Flowonix Medical, Inc.
12861
In Commercial Distribution
- 00810335020181 ()
- Infusion pump programmer
The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.
Flowonix Medical, Inc.
12860
In Commercial Distribution
- 00810335020174 ()
- Infusion pump programmer
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).
Flowonix Medical, Inc.
12828
In Commercial Distribution
- 00810335020167 ()
- Infusion pump programmer
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.
Flowonix Medical, Inc.
11828
In Commercial Distribution
- 00810335020129 ()
- Infusion pump programmer
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 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
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
EZY-ON
THE HELPING HAND COMPANY (LEDBURY) LIMITED
EZY-ON TALL NEW
In Commercial Distribution
- 05050962164192 ()
HA0835
- Assistive sock/pantyhose dressing device
6" X 9" DRUG SCAN BAG, 1.5MIL, W/2MIL BACK POUCH, 3" X 4" DESICCANT PAD, ADHESIVE TAPE,
Asp Global, LLC
BAG-TOX-DS(NEW DESIGN)
In Commercial Distribution
- 00840216114982 ()
- General specimen receptacle transport container