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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
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution
- 00860007599118 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
PAIGE.AI, INC.
2.X
In Commercial Distribution
- 00860007599101 ()
- Pathology information system
No Description
Aiq Global, Inc.
2.x
In Commercial Distribution
- 00860007104916 ()
- 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
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
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution
- 00860135001934 ()
- Electronic acoustic stethoscope
No Description
Whoop, Inc.
1.x
In Commercial Distribution
- 00860012964819 ()
- Electrocardiograph, home-use
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
- Vulnerable patient home-monitoring software, professional-only