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Vascular Flow Analysis System
VASSOL, INC.
VS5060
In Commercial Distribution
- 00867170000106 ()
- MRI system application software
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution.
STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.
Spintech, Inc.
2.3
In Commercial Distribution
- 00866463000465 ()
REF 200008
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
Spintech, Inc.
2
Not in Commercial Distribution
- 00866463000441 ()
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
Spintech, Inc.
1.1
Not in Commercial Distribution
- 00866463000410 ()
- MRI system application software
The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be viewed on the GPS Tablet during surgery, which surgeons can use to reference against the intraoperative images captured during the procedure. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet using the Radlink Wireless C-Arm Kit.
RADLINK, INC.
TABLET
In Commercial Distribution
- 00866389000112 ()
- Radiology information system
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.6
Not in Commercial Distribution
- 00864747000279 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.4
Not in Commercial Distribution
- 00864747000262 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.3
Not in Commercial Distribution
- 00864747000255 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.2
Not in Commercial Distribution
- 00864747000248 ()
- MRI system application software
NeoSoft’s CAKE product is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic breast MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. CAKE may perform additional functions to aid in the analysis and viewing of dynamic studies including registration of serial MR acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multi-planar reformats, maximum intensity projections, image averaging, and subtractions.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CAKE analysis.
NEOSOFT LLC
3.0.0
In Commercial Distribution
- 00864747000231 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.1
Not in Commercial Distribution
- 00864747000224 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.0
Not in Commercial Distribution
- 00864747000217 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
3.0.1
Not in Commercial Distribution
- 00864747000200 ()
- MRI system application software
No Description
CORTECHS LABS INC
LQ
In Commercial Distribution
- 00863725000317 ()
- MRI system application software
No Description
CORTECHS LABS INC
NQ
In Commercial Distribution
- 00863725000300 ()
- MRI system application software
Surgical Navigation Advanced Platform (SNAP) Patient Engagement Mobile System
SURGICAL THEATER LLC
PE SNAP
In Commercial Distribution
- 00863157000374 ()
- Surgical planning/navigation-enhancement system
Surgical Navigation Advanced Platform (SNAP) Patient Engagement Desktop System
SURGICAL THEATER LLC
VR MSNAP
In Commercial Distribution
- 00863157000367 ()
- Surgical planning/navigation-enhancement system
SuRgical Planner (SRP) Clinic Viewer Desktop
SURGICAL THEATER LLC
All-in-One
In Commercial Distribution
- 00863157000350 ()
- Surgical simulation system
SuRgical Planner (SRP) Clinic Viewer Notebook
SURGICAL THEATER LLC
Notebook
In Commercial Distribution
- 00863157000343 ()
- Surgical simulation system
SuRgical Planner (SRP) Desktop System
SURGICAL THEATER LLC
SRP
In Commercial Distribution
- 00863157000336 ()
- Surgical simulation system
Endoscope Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
Endo SNAP
In Commercial Distribution
- 00863157000329 ()
- Surgical planning/navigation-enhancement system
Surgical Navigation Advanced Platform (SNAP) Desktop System
SURGICAL THEATER LLC
VR SNAP
In Commercial Distribution
- 00863157000312 ()
- Surgical planning/navigation-enhancement system
Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SNAP
In Commercial Distribution
- 00863157000305 ()
- Surgical planning/navigation-enhancement system
Remote Central Station - Vidco Protocol
VIDCO, INC
MDP2040-0200
In Commercial Distribution
- 00863067000334 ()
- Centralized patient monitor
Remote Viewer and Charting Station for Labor and Delivery Central Station.
VIDCO, INC
MDP2040-0600RV
In Commercial Distribution
- 00863067000327 ()
- Centralized patient monitor
Labor and Delivery Central Station
VIDCO, INC
MDP2020-0600
In Commercial Distribution
- 00863067000310 ()
- Centralized patient monitor
Remote Central Station
VIDCO, INC
MDP2040-0100
In Commercial Distribution
- 00863067000303 ()
- Centralized patient monitor
No Description
TIME MEDICAL SYSTEMS
TMS-MRI-3500wb-02
In Commercial Distribution
- 00862694000304 ()
- Weight: 18500 Kilogram
- Full-body MRI system, permanent magnet
No Description
VERATHON INC
ScanPoint®
In Commercial Distribution
- 00879123006127 ()
- Ultrasound imaging system application software
No Description
VERATHON INC
ScanPoint Local Client
In Commercial Distribution
- 00879123004239 ()
0900-1009
- Ultrasound imaging system application software
GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
G-TECH MEDICAL, INC.
Gen 2
In Commercial Distribution
- 00860011391500 ()
- 00860011391517 ()
- Length: 3.3 Inch
1001
- Wearable multiple vital physiological parameter monitoring system
No Description
Sirona Medical, Inc.
Model1
In Commercial Distribution
- 00860011175803 ()
- Radiology information system
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution
- 00860010575307 ()
- Ultrasound imaging system application software
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution
- 00860008932204 ()
- Wearable multiple vital physiological parameter monitoring system
MD52 Rx device
Amimon Inc.
MD52 Rx device - MDWL2_B3P1RX
In Commercial Distribution
- 00860014100673 ()
MDWL2_B3P1RX
- Medical image management system
MD11 Rx device
Amimon Inc.
MD11 Rx device - MDWL1_B1N1RX
In Commercial Distribution
- 00860014100635 ()
MDWL1_B1N1RX
- Medical image management system
MD11 Tx device
Amimon Inc.
MD11 Tx device - MDWL1_C1N1TX
In Commercial Distribution
- 00860014100628 ()
MDWL1_C1N1TX
- Medical image management system
MD62 Tx device
Amimon Inc.
MD62 Tx device - MDWL2_B1J1TX
In Commercial Distribution
- 00860014100604 ()
MDWL2_B1J1TX
- Medical image management system
MD52 Tx device
Amimon Inc.
MD52 Tx device - MDWL2_B1P1TX
In Commercial Distribution
- 00860014100666 ()
MDWL2_B1P1TX
- Medical image management system
MD62 Rx device
Amimon Inc.
MD62 Rx device - MDWL2_B1J1RX
In Commercial Distribution
- 00860014100611 ()
MDWL2_B1J1RX
- Medical image management system