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Cercare Medical Neurosuite with Capillary Function ver. 15
Cercare Medical A/S
15
In Commercial Distribution
- 05745000308163 ()
- Radiological PACS software
Cercare Medical Neurosuite ver. 15
Cercare Medical A/S
15
In Commercial Distribution
- 05745000308156 ()
- Radiological PACS software
Cercare Medical Neurosuite with Capillary Function ver. 14
Cercare Medical A/S
14
- Radiological PACS software
Cercare Medical Neurosuite ver. 14
Cercare Medical A/S
14
- Radiological PACS software
No Description
Cercare Medical A/S
2023-06-01
Not in Commercial Distribution
- 05745000308071 ()
- Radiological PACS software
No Description
Cercare Medical A/S
2023-06-01
Not in Commercial Distribution
- 05745000308057 ()
- Radiological PACS software
Cercare Medical Neurosuite with Capillary Function, release 2023-02-01 and prior
Cercare Medical A/S
CMN with Capillary Function (MR)
Not in Commercial Distribution
- 05745000308019 ()
- Radiological PACS software
No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution
- 00860011882022 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution
- 00860011850922 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution
- 00860011850915 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-311
In Commercial Distribution
- 00860011850908 ()
- Cognitive assessment software
NeuroEyeCoach is a saccadic training program for those who have vision disorders caused by a stroke or brain injury. It is designed to address a patient’s difficulty with eye movement and the integration of visual information. The therapy re-trains the patient’s ability to scan the environment, re-integrate left and right vision, and make the most of their remaining visual field. NeuroeyeCoach is self-adaptive and adjusts the task difficulty to the patient's deficit and stage of recovery while encouraging eye movement efficiency.
Novavision, Inc.
NEC 2.00
In Commercial Distribution
- 00860010599716 ()
- Vision training software
VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.
Novavision, Inc.
VRT 7.0
In Commercial Distribution
- 00860010599709 ()
- Vision training software
No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution
- 00860009693401 ()
- Cognitive assessment software
CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instructions that can be administered in office.
CNS Vital Signs, LLC
1.1.4
In Commercial Distribution
- 00860013886134 ()
- Psychological assessment software
CNS Vital Signs cognitive testing web platform. A set of cognitive tests and clinical questionnaire that can be administered in office or remotely.
CNS Vital Signs, LLC
2.0.6
In Commercial Distribution
- 00860013886103 ()
- Psychological assessment software
Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes.
The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.
Neurotrack Technologies, Inc.
1.1.0
In Commercial Distribution
- 00860009484504 ()
- Cognitive assessment software
The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
2.18.2
In Commercial Distribution
- 00860011623915 ()
- Radiological PACS software
Simpleware Medical image processing.
Applicable software versions (UDI-PI)
(01)00860011545705(8012)V-2024.06
(01)00860011545705(8012)W-2024.12
(01)00860011545705(8012)X-2025.06
SYNOPSYS, INC.
V-2024.06 -
In Commercial Distribution
- 00860011545705 ()
- Radiological PACS software
BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution
- 00860011154501 ()
- Cognitive assessment software
No Description
Anthrotronix, Inc.
1.0
In Commercial Distribution
- 00860011042105 ()
- Cognitive assessment software
A collection of neuropsychological tests for health professionals and researchers. The assessment measures cognitive function and performs a complete cognitive screening, allowing users to quickly, conveniently, and accurately assess the well-being and cognitive profile of patients and research participants. Applicable via in-person consultation, in a laboratory setting, and remotely.
Cognifit, Inc.
PRO
In Commercial Distribution
- 00860009958104 ()
- Cognitive assessment software
CNS Vital Signs cognitive testing installed local software platform. A set of cognitive tests and clinical questionnaires administered in office without an internet connection.
CNS Vital Signs, LLC
4.0.107
In Commercial Distribution
- 00860013886110 ()
- Psychological assessment software
No Description
VARIAN MEDICAL SYSTEMS, INC.
18.1
In Commercial Distribution
- 00855141006349 ()
- Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
18.0
In Commercial Distribution
- 00855141006202 ()
- Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
17.0
In Commercial Distribution
- 00855141006103 ()
- Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
16.1
In Commercial Distribution
- 00855141006080 ()
- Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
16.0
In Commercial Distribution
- 00855141006073 ()
- Radiation therapy software
No Description
Varian Medical Systems Finland Oy
15.6
In Commercial Distribution
- 00855141006066 ()
- Radiation therapy software
No Description
Varian Medical Systems Finland Oy
15.5
In Commercial Distribution
- 00855141006059 ()
- Radiation therapy software