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No Description
Tilite
TiLite X
In Commercial Distribution
- 00853316008129 ()
- Push-rim manual wheelchair, non-bariatric
No Description
Tilite
Aero X
In Commercial Distribution
- 00853316008068 ()
- Push-rim manual wheelchair, non-bariatric
Aer X is a portable Oxygen concentrator
3B MEDICAL, INC.
Aer X
In Commercial Distribution
- 00853041003000 ()
021000M
- Mobile/portable oxygen concentrator
Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers.
GLOOKO, INC.
18.x
In Commercial Distribution
- 00855093008019 ()
- Clinical management support software
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution
- 00855093008002 ()
- Clinical management support software
No Description
Sysmex America, Inc.
1.X
In Commercial Distribution
- 00664369000851 ()
- Clinical laboratory information system application software
No Description
Sysmex America, Inc.
5.X
In Commercial Distribution
- 00664369000752 ()
- Clinical laboratory information system
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
Surround 5.x
Gpi Usa, Inc.
5.x
- Blood bank information system