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Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution
- 00860006793708 ()
2.0.0.0
- Blood bank information system application software
Gro3X DIU system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Gro3X DIU system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
Gro3x, Inc.
DIU-3D-71-001
In Commercial Distribution
- 00860006572501 ()
- Dental milling system, CAD/CAM, chairside
Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a stand alone device to improve the appearance of cellulite.
Soliton Inc
Rapid Acoustic Pulse Device (RAP) GEN-2.2
In Commercial Distribution
- 00860006515102 ()
1004900-MDC-003
- General/multiple surgical diode laser system
No Description
Aerus LLC
F170A
In Commercial Distribution
- 00860006514808 ()
- High-efficiency filter air cleaner, mobile
The HMS-1000 hyperbaric chamber series is a Class B, monoplace hyperbaric chamber designed to treat one (1) patient to a maximum operating pressure of three (3) Atmospheres Absolute (ATA) (~ 29.4 psi). The chamber uses 100% oxygen as both the pressurization and hyperbaric treatment gas. The overall external length of the horizontal cylinder configuration is 8.75 feet. Its internal diameter is 33.5 inches. It is constructed of acrylic, aluminum, and fine-grade steel. Single operator pressure control is achieved via a simple industrial Programmable Logic Device (PLD) controller. A low-voltage patient intercom provides communications between the patient in the chamber and the external chamber operators. HMS-1000 is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-1000
In Commercial Distribution
- 00860006478964 ()
- Hyperbaric chamber, stationary
The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindrical geometry. The HMS-2000 hyperbaric chamber family of products is designed with non-dedicated seating, providing flexibility in managing seating arrangements. The diameter of the HMS-2000 varies in size; thereby enabling the ability to increase the patient capacity from three (3) to four (4) seated patients. An extension nozzle is attached to the chamber hull which provides the unique capability to treat one (1) patient in the supine versus seated position. The maximum allowable working pressure is three (3) Atmospheres Absolute (ATA) (~29.4psi). The control and operation of the HMS-2000 is performed from a hull mounted control console. The HMS-2000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-2000
In Commercial Distribution
- 00860006478940 ()
- Hyperbaric chamber, stationary
The HMS-4000 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a horizontal cylindrical geometry. Configurations vary from one (1) to three (3) compartments. These chambers are capable of administering hyperbaric oxygen therapy treatments to four (4) up to twenty-four (24) patients simultaneously. These chamber models comprise the HMS 4000 Horizontal Cylindrical Multiplace Hyperbaric Chamber System Product Family. Each system consists of a multiplace hyperbaric chamber with several major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Design pressures range from 3ATA (~29.4psi) up to 6ATA (~73.5psi). The HMS-4000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-4000
In Commercial Distribution
- 00860006478926 ()
- Hyperbaric chamber, stationary
The HMS-5000-12 is a Class A, pressure vessel for human occupancy (PVHO) that is designed in a rectangular geometry. It has two (2) compartments and is capable of administering hyperbaric oxygen therapy treatments up to twelve (12) patients simultaneously. It is one of the models contained within the HMS 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family. It is comprised of a multiplace hyperbaric chamber with a number of major subsystems that are interconnected to form a complete system, which includes an operation control system that uses computer control technology. Pressures up to 6ATA (~73.5psi). The HMS-5000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.
Hyperbaric Modular Systems Inc.
HMS-5000-12
In Commercial Distribution
- 00860006478902 ()
- Hyperbaric chamber, stationary
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
Curemetrix, Inc.
V1.6
In Commercial Distribution
- 00860006442699 ()
- Radiology DICOM image processing application software
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection and should not be used alone to make any diagnosis and/or treatment decisions.
cmAngio is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution
- 00860006442682 ()
- Radiology DICOM image processing application software