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No Description
EBM TECHNOLOGIES INCORPORATED
SoliPACS™ Server
In Commercial Distribution
- 04719878879910 ()
- Radiological PACS software
EasyCare Tx V9.0 CD ASSY
RESMED PTY LTD
25945
In Commercial Distribution
- 00619498259458 ()
25945
- Ventilator application software
EasyCare Tx CD ASSY
RESMED PTY LTD
25944
In Commercial Distribution
- 00619498259441 ()
25944
- Ventilator application software
RESSCAN DATA CARD MODULE
RESMED PTY LTD
22915
In Commercial Distribution
- 00619498229154 ()
22915
- Ventilator application software
Android
RESMED PTY LTD
22244
In Commercial Distribution
- 00619498222445 ()
- Ventilator application software
iOS
RESMED PTY LTD
22243
In Commercial Distribution
- 00619498222438 ()
- Ventilator application software
AIRVIEW
RESMED PTY LTD
22240
In Commercial Distribution
- 00619498222407 ()
22240
- Ventilator application software
RESSCAN DATA CARD READER
RESMED PTY LTD
22207
In Commercial Distribution
- 00619498222070 ()
22207
- Ventilator application software
RESSCAN USB ADAPTER
RESMED PTY LTD
22203
In Commercial Distribution
- 00619498222032 ()
22203
- Ventilator application software
ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution
- 00619498313365 ()
31336
- Ventilator application software
RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution
- 00619498313358 ()
31335
- Ventilator application software
RESSCAN V6.0.1 CD ASSY
RESMED PTY LTD
31334
In Commercial Distribution
- 00619498313341 ()
31334
- Ventilator application software
RESSCAN V6.0 CD ASSY
RESMED PTY LTD
31333
In Commercial Distribution
- 00619498313334 ()
31333
- Ventilator application software
RESSCAN V 5.9 CD ASSY
RESMED PTY LTD
31332
In Commercial Distribution
- 00619498313327 ()
31332
- Ventilator application software
RESSCAN V 5.8 CD ASSY
RESMED PTY LTD
31330
In Commercial Distribution
- 00619498313303 ()
31330
- Ventilator application software
RESSCAN V 5.7 CD ASSY
RESMED PTY LTD
31329
In Commercial Distribution
- 00619498313297 ()
31329
- Ventilator application software
RESSCAN V 5.5 CD ASSY
RESMED PTY LTD
31327
In Commercial Distribution
- 00619498313273 ()
31327
- Ventilator application software
AirView
RESMED PTY LTD
4.2
In Commercial Distribution
- 00619498000845 ()
- Ventilator application software
Standard Imaging IMSure 3D software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91355
In Commercial Distribution
- 00850019946604 ()
91355
- Radiation therapy software
Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91365
In Commercial Distribution
- 00850019946543 ()
91365
- Radiation therapy software
ULTRASOUND DATA ANALYSIS SYSTEM
FUJIFILM HEALTHCARE CORPORATION
DAS-RS1
- Radiological PACS software
No Description
TOPCON CORPORATION
IMAGEnet 6
In Commercial Distribution
- 04562123288582 ()
- Ophthalmology PACS software
No Description
TOPCON CORPORATION
IMAGEnet 5
In Commercial Distribution
- 04562123288308 ()
- Camera application software
ULTRASOUND DATA ANALYSIS SYSTEM
HITACHI, LTD.
DAS-RS1
Not in Commercial Distribution
- 04562122958639 ()
- Radiological PACS software
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution
- 00863284000315 ()
- Radiation therapy software
The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Kit
In Commercial Distribution
- 00862290000333 ()
- Cognitive assessment software
The Test of Variables of Attention (T.O.V.A.) USB Device is a USB-peripheral that precisely and accurate records and securely stores a subject's responses to the T.O.V.A. test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
USB Device
In Commercial Distribution
- 00862290000302 ()
- Cognitive assessment software
vRad PACS 2
Vrad
2
In Commercial Distribution
- 00862234000313 ()
- Radiological PACS software
vRad PACS 1
Vrad
1
In Commercial Distribution
- 00862234000306 ()
- Radiological PACS software
The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury.
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.
The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.5.0.7
In Commercial Distribution
- 00860334002121 ()
- Psychological assessment software
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.
The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.5
In Commercial Distribution
- 00860334002114 ()
- Psychological assessment software
The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The ANAM Military Battery provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.
The ANAM Military Battery provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test results to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Military Battery will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.3
In Commercial Distribution
- 00860334002107 ()
- Psychological assessment software
eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution
- 00866994000255 ()
- Radiological PACS software
eRAD PACS Evolution
Erad, Inc.
8.0
In Commercial Distribution
- 00866994000224 ()
- Radiological PACS software
eRAD PACS v7.3
Erad, Inc.
7.3
In Commercial Distribution
- 00866994000217 ()
- Radiological PACS software
eRAD PACS v7.2
Erad, Inc.
7.2
In Commercial Distribution
- 00866994000200 ()
- Radiological PACS software
Standard Imaging QA Pilot is cloud-based software tool that allows users to enter, store, and analyze data accumulated in the clinical radiation oncology setting from quality assurance processes.
STANDARD IMAGING INC.
91348
In Commercial Distribution
- 00866562000298 ()
91348
- Radiation therapy software
Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems.
STANDARD IMAGING INC.
v1
In Commercial Distribution
- 00866562000243 ()
91350
- Radiation therapy software
Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
STANDARD IMAGING INC.
v3
In Commercial Distribution
- 00866562000229 ()
91326
- Radiation therapy software
The Radiation Analyzer (RAy)is a film dosimetry application used to verify complex radiation therapy treatment plans.
AGILE RADIOLOGICAL TECHNOLOGIES
5.0
Not in Commercial Distribution
- 00866498000300 ()
Ray 5.0
- Radiation therapy software
Final software release for UDI-DI: T-2022.03.
Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning.
For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.
The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
SYNOPSYS, INC.
S-2021.06 onwards
Not in Commercial Distribution
- 00863520000390 ()
- Radiological PACS software
No Description
SYNOPSYS, INC.
R-2021.03
Not in Commercial Distribution
- 00863520000383 ()
- Radiological PACS software
No Description
SYNOPSYS, INC.
R-2020.09
Not in Commercial Distribution
- 00863520000376 ()
- Radiological PACS software
No Description
SYNOPSYS, INC.
Q-2020.03
Not in Commercial Distribution
- 00863520000369 ()
- Radiological PACS software
No Description
SYNOPSYS, INC.
Q-2020.06
Not in Commercial Distribution
- 00863520000352 ()
- Radiological PACS software
No Description
SYNOPSYS, INC.
P-2019.09
Not in Commercial Distribution
- 00863520000345 ()
- Radiological PACS software
No Description
SYNOPSYS, INC.
O-2018.12
Not in Commercial Distribution
- 00863520000338 ()
- Radiological PACS software
No Description
SYNOPSYS, INC.
N-2018.03
Not in Commercial Distribution
- 00863520000321 ()
- Radiological PACS software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution
- 00864127000356 ()
- Cognitive assessment software
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
IMPACT APPLICATIONS, INC.
4
In Commercial Distribution
- 00864127000349 ()
- Cognitive assessment software