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No Description
VARIAN MEDICAL SYSTEMS, INC.
15.0
In Commercial Distribution
- 00856545006003 ()
TM60010004
- Radiation therapy simulation system
The TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
MINXRAY, INC.
TR90BH
In Commercial Distribution
- 00858846007253 ()
- Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a podiatric mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HFP24 Podiatric X-ray unit
In Commercial Distribution
- 00858846007246 ()
- Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors.
MINXRAY, INC.
HFP40 Portable X-ray unit
In Commercial Distribution
- 00858846007239 ()
- Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.TW.1202.R
In Commercial Distribution
- 00858846007222 ()
- Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HF1202H Portable X-ray
In Commercial Distribution
- 00858846007000 ()
- Portable basic diagnostic x-ray system, analogue
Ultrasound imaging system main unit
Cortex Technology ApS
08
In Commercial Distribution
- 05710188039000 ()
A0390008
- Ultrasound imaging system operator console
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HF120/60HPPWV PowerPlus Portable X-ray
In Commercial Distribution
- 00858846007024 ()
- Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HF100H+ Portable X-ray
In Commercial Distribution
- 00858846007017 ()
- Portable basic diagnostic x-ray system, analogue
No Description
Icad, Inc.
2.1
In Commercial Distribution
- 00858012005960 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
V2
Not in Commercial Distribution
- 00858012005939 ()
- Basic diagnostic x-ray system application software
"PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.
Icad, Inc.
V3.4
In Commercial Distribution
- 00858012005922 ()
D70141, D70142, D70160
- Basic diagnostic x-ray system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005915 ()
CT-102
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005908 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005892 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005885 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005878 ()
DSC014-03-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005861 ()
D4D0192
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005854 ()
DSC017-04-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005847 ()
DSC017-04-ROW
- Basic diagnostic x-ray system application software