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A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans.
RADIALOGICA LLC
1.x
In Commercial Distribution
- 00863284000308 ()
- Radiology DICOM image processing application software
No Description
SCIMAGE, INC
3.x
In Commercial Distribution
- 00861917000305 ()
- Radiological PACS software
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution
- 00859699006059 ()
- Patient health record information system
- Radiological PACS software
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.2.9.X
In Commercial Distribution
- 00859699006042 ()
- Radiological PACS software
- Patient health record information system
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.
Subtle Medical, Inc.
2.x
In Commercial Distribution
- 00860000171212 ()
- Radiology DICOM image processing application software
SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI).
Subtle Medical, Inc.
2.x
In Commercial Distribution
- 00860000171205 ()
- Radiology DICOM image processing application software
Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
KOIOS MEDICAL, INC.
3.x
In Commercial Distribution
- 00860002545714 ()
- Ultrasound imaging system application software
cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.
cNeuro™ cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).
cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.
Combinostics Oy
1.0.x
In Commercial Distribution
- 06430070845012 ()
- Radiology DICOM image processing application software
cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.
The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.
cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration.
PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy.
cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.
Combinostics Oy
1.0.x
In Commercial Distribution
- 06430070844015 ()
- Radiology DICOM image processing application software
https://www.combinostics.com/cmri/
Combinostics Oy
2.0.X
In Commercial Distribution
- 06430070841021 ()
- Radiology DICOM image processing application software
No Description
PaloDEx Group Oy
6.x
In Commercial Distribution
- 06430035872367 ()
213248
- Stationary panoramic/tomographic dental x-ray system, digital
No Description
PaloDEx Group Oy
11.x
In Commercial Distribution
- 06430035872350 ()
213183
- Stationary panoramic/tomographic dental x-ray system, digital
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE X
In Commercial Distribution
- 06903053003902 ()
- General-purpose ultrasound imaging system
Acuvision X is a surgical microscope intended for the illumination and magnification of the surgical area during surgical procedures (except ophthalmic surgeries).
Changzhou Sifary Medical Technology Co., Ltd.
Acuvision X
In Commercial Distribution
- 06941877821456 ()
5380009
- General-purpose surgical microscope
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images.
StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.
Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution
- 00882916000530 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution
- 00882916000516 ()
v1.x and v2.0
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
6.x
In Commercial Distribution
- 00882916000028 ()
- MRI system application software
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution
- 00882916000011 ()
- MRI system application software
No Description
Tilite
TiLite X
In Commercial Distribution
- 00853316008129 ()
- Push-rim manual wheelchair, non-bariatric