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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
No Description
Aiq Global, Inc.
2.x
In Commercial Distribution
- 00860007104916 ()
- Radiological PACS software
The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient’s temporal acoustic windows.
Novasignal Corp.
1.x
Not in Commercial Distribution
- 00850681007122 ()
NA-RBT1
- Noninvasive vascular ultrasound system, line-powered
The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
Novasignal Corp.
1.x
Not in Commercial Distribution
- 00850681007115 ()
NA-DSP2
- Noninvasive vascular ultrasound support kit
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.
HYLAND LLC
5.2.X
In Commercial Distribution
- 00850677007419 ()
CS.5.2
- Radiological PACS software
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including
patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client
configuration, and the flow of data between modalities and destination DICOM systems. PACSgear
HYLAND LLC
5.1.X
- Radiological PACS software
Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).
HYLAND LLC
1.X
In Commercial Distribution
- 00850677007389 ()
- Radiological PACS software
No Description
HYLAND LLC
2.X
Not in Commercial Distribution
- 00850677007310 ()
- Radiological PACS software
Encounter Manager
HYLAND LLC
2.X
Not in Commercial Distribution
- 00850677007303 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007297 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007280 ()
- Radiological PACS software
Web Forms
HYLAND LLC
4.X
Not in Commercial Distribution
- 00850677007273 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007266 ()
- Radiological PACS software
Core Server
HYLAND LLC
5.X
Not in Commercial Distribution
- 00850677007259 ()
- Radiological PACS software
Media Writer Web
HYLAND LLC
1.X
In Commercial Distribution
- 00850677007242 ()
- Radiological PACS software
EHR Gateway
HYLAND LLC
2.X
In Commercial Distribution
- 00850677007235 ()
- Radiological PACS software
Web Forms, Mod Link Web Forms
HYLAND LLC
3.X
In Commercial Distribution
- 00850677007228 ()
- Radiological PACS software
Mod LInk
HYLAND LLC
3.X
In Commercial Distribution
- 00850677007211 ()
- Radiological PACS software
Image Link Encounter Workflow
HYLAND LLC
1.X
In Commercial Distribution
- 00850677007204 ()
- Radiological PACS software
Image Link
HYLAND LLC
2.X
In Commercial Distribution
- 00850677007198 ()
- Radiological PACS software
PACS Scan Web
HYLAND LLC
2.X
In Commercial Distribution
- 00850677007181 ()
- Radiological PACS software
PACSgear Core Server
HYLAND LLC
4.X
In Commercial Distribution
- 00850677007167 ()
- Radiological PACS software
- Medical image management system
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution
- 00850677007150 ()
PSM2.2.2
- Radiological PACS software
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution
- 00850921007172 ()
- Extracorporeal ultrasound imaging transducer, hand-held
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution
- 00852426007022 ()
- CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution
- 00852426007015 ()
- CT system application software
VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution
- 00852426007008 ()
- CT system application software
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution
- 00851147007120 ()
- Radiation therapy software
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution
- 00860135001934 ()
- Electronic acoustic stethoscope
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.2.x
In Commercial Distribution
- 05902729753630 ()
- CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.1.x
Not in Commercial Distribution
- 05902729753500 ()
- CAD/CAM software
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution
- 05902729753487 ()
- Dental treatment application software
Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution
- 05902729752954 ()
- Dental treatment application software