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X-MARK PROBE TOOL
XNAV TECHNOLOGIES LLC
P010673
In Commercial Distribution
- 00817421020995 ()
P010673
- Surgical planning/navigation-enhancement system
LOANER PRACTICE KIT
XNAV TECHNOLOGIES LLC
P010670
In Commercial Distribution
- 00817421020988 ()
- Surgical planning/navigation-enhancement system
X-Guide 2.3.6 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution
- 00817421020971 ()
- Surgical planning/navigation-enhancement system
X-Guide 2.3.5 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution
- 00817421020964 ()
- Surgical planning/navigation-enhancement system
X-Guide 2.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution
- 00817421020896 ()
- Surgical planning/navigation-enhancement system
X-Guide System Software Version 2.3.0
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution
- 00817421020797 ()
P008542
- Surgical planning/navigation-enhancement system
CALIBRATION DISC ASM - FRICTION GRIP
XNAV TECHNOLOGIES LLC
P010227
In Commercial Distribution
- 00817421020735 ()
P010227
- Surgical planning/navigation-enhancement system
HANDPIECE CONNECTOR ASM. - BIEN AIR
XNAV TECHNOLOGIES LLC
P009350
In Commercial Distribution
- 00817421020728 ()
P009350
- Surgical planning/navigation-enhancement system
COMPUTER MOUSE
XNAV TECHNOLOGIES LLC
P008697
In Commercial Distribution
- 00817421020711 ()
P008697
- Surgical planning/navigation-enhancement system
HANDPIECE CALIBRATION DISC
XNAV TECHNOLOGIES LLC
P007747
In Commercial Distribution
- 00817421020186 ()
P007747
- Surgical planning/navigation-enhancement system
No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution
- B201CGONE1 ()
- B201CGONE0 ()
- Ultrasound imaging system application software
No Description
SUN NUCLEAR CORP.
159ABR
In Commercial Distribution
- B136159ABR0 ()
- Mammographic x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
159A
In Commercial Distribution
- B136159A0 ()
- Mammographic x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
156D
In Commercial Distribution
- B136156D0 ()
- Mammographic x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
156
In Commercial Distribution
- B1361560 ()
- Mammographic x-ray phantom, test object
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.75.20171019
In Commercial Distribution
- B133NEUROQ1 ()
- Neurosurgical ultrasound navigation system application software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.6.20131127
In Commercial Distribution
- B133NEUROQ0 ()
- Neurosurgical ultrasound navigation system application software
WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also
intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical
images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging
examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution
- B127WP90 ()
n/a
- Medical image management system
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution
- B118314170 ()
- Ultrasound imaging system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution
- B118314160 ()
- Ultrasound imaging system application software
Portable X-Ray System-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR301
In Commercial Distribution
- 00817100020353 ()
- Portable basic diagnostic x-ray system, digital
SR-130 + DR Portable VIZION M portavle X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR310
In Commercial Distribution
- 00817100020124 ()
- Portable basic diagnostic x-ray system, digital
SR-130 + DR Portable X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR300
In Commercial Distribution
- 00817100020117 ()
- Portable basic diagnostic x-ray system, digital
No Description
ICU MEDICAL, INC.
3304
In Commercial Distribution
- 10610586036347 ()
- Multiple vital physiological parameter monitoring system, clinical
SYNERGYHD3 DICOM KEY
ARTHREX, INC.
AR-3200-1020
In Commercial Distribution
- 00888867100619 ()
AR-3200-1020
- Medical image management system
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution
- B3945000034040 ()
500-0034-04
- Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution
- B3945000034030 ()
500-0034-03
- Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution
- B3945000034020 ()
500-0034-02
- Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution
- B3945000034010 ()
500-0034-01
- Multiple vital physiological parameter monitoring system, clinical
Athena GTX Device Management Suite - Android
ATHENA GTX, INC.
ADMS Android Software
In Commercial Distribution
- B3943950010000 ()
395-0010-00
- Centralized patient monitor