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No Description
SYRMA JOHARI MEDTECH LIMITED
X FORCE
In Commercial Distribution
- 08908008085048 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
SYRMA JOHARI MEDTECH LIMITED
X Trainer
In Commercial Distribution
- 08908008085055 ()
- Physical therapy transcutaneous electrical stimulation system, line-powered
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000055 ()
- Phonocardiograph
- Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000048 ()
- Phonocardiograph
- Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System.
The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000031 ()
- Phonocardiograph
- Stethoscope application software
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
3.X
In Commercial Distribution
- 00850005944430 ()
81-02315-00R
- Magnetic neural stimulation system
NeuroStar Mobile Console, recertified
NEURONETICS, INC.
2.X
In Commercial Distribution
- 00850005944423 ()
81-01315-00R
- Magnetic neural stimulation system
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
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.
Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution
- 00860002545707 ()
- Ultrasound imaging system application software
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution
- 00860001700176 ()
- Footstool
- Flat panel x-ray detector/film cassette weight-bearing protector
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
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
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
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
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
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
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
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 Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution
- 00850677007150 ()
PSM2.2.2
- 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
No Description
HYLAND LLC
2.X
Not in Commercial Distribution
- 00850677007310 ()
- Radiological PACS software
Web Forms
HYLAND LLC
4.X
Not in Commercial Distribution
- 00850677007273 ()
- 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
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
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