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VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
O N DIAGNOSTICS LLC
A
In Commercial Distribution
- 00860000233118 ()
- Radiology DICOM image processing application software
VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.
O N DIAGNOSTICS LLC
A
In Commercial Distribution
- 00860000233101 ()
- Radiology DICOM image processing application software
prolaio Convenience Kit - Model A
Prolaio, Inc.
A
In Commercial Distribution
- 00850071330106 ()
- Electrocardiography monitoring system receiver
931
Eca Medical Instruments
A
In Commercial Distribution
- 00857676008324 ()
991067S
- Orthopaedic surgical procedure kit, non-medicated, single-use
930
Eca Medical Instruments
A
In Commercial Distribution
- 00857676008263 ()
991066S
- Orthopaedic surgical procedure kit, non-medicated, single-use
pNeuton Ventilator, model A
AIRON CORPORATION
A
In Commercial Distribution
- 00853678006009 ()
- Depth: 7.3 Inch
- Width: 10.0 Inch
- Height: 5.0 Inch
- Weight: 6.5 Pound
20052
- Portable pneumatic ventilator
The QT Scanner 2000 Model A is an automated and software-controlled ultrasound system for breast imaging that can be operated by a single operator. The system consists of an examination table, a scan tank, image processing electronics, operator console, breast retention device, and ultrasound beam forming electronics. The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
Qt Imaging, Inc.
A
In Commercial Distribution
- 00852619008003 ()
100366
- General-purpose ultrasound imaging system
The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Regenesis Biomedical, Inc.
A
In Commercial Distribution
- 00868924000038 ()
- Short-wave diathermy treatment system, home-use
InnoVoyce VYLO Eye Safety Filter Leica
Innovoyce LLC
A
In Commercial Distribution
- 00860004755999 ()
ASY-300143
- General/multiple surgical laser system beam guide, reusable
InnoVoyce VYLO 30W 455nm Laser
Innovoyce LLC
A
In Commercial Distribution
- 00860004755982 ()
ASY-300134
- General/multiple surgical diode laser system