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X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution
- 05415067046659 ()
ENSITE-TF-02
- Cardiac mapping system application software
X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-01
In Commercial Distribution
- 05415067046642 ()
ENSITE-OTAC-01
- Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.2
In Commercial Distribution
- 05415067046215 ()
ENSITE-SW-1.1.2
- Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
H704001
In Commercial Distribution
- 05415067046185 ()
H704001
- Cardiac mapping system application software
WBR Imaging X + X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177121 ()
- SPECT system application software
WBR Imaging X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177114 ()
- SPECT system application software
WBR Imaging X + X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177091 ()
- SPECT system application software
WBR Imaging X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177084 ()
- SPECT system application software
WBR Imaging X + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177077 ()
- SPECT system application software
WBR Imaging X + X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177060 ()
- SPECT system application software
WBR Imaging X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177053 ()
- SPECT system application software
WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177046 ()
- SPECT system application software
WBR Imaging X + X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177022 ()
- SPECT system application software
WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177008 ()
- SPECT system application software
Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution
- 05414734219211 ()
H21921
- Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution
- 05414734214636 ()
75-05772-001
- Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution
- 05414734214841 ()
75-06066-001
- Cardiac mapping system application software
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion
Indications for use:
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution
- 05600250059022 ()
- MRI system application software
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution
- 00850014885021 ()
- Ultrasound imaging system application software
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution
- 00850011790199 ()
MREPLUSV3
- MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution
- 00850011790014 ()
- MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution
- 00850011790007 ()
- MRI system application software
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution
- 00850018318013 ()
- Ultrasound imaging system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution
- 00850017464001 ()
- Ultrasound imaging system application software
WBR Imaging X + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177107 ()
- SPECT system application software
WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177039 ()
- SPECT system application software
WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution
- 00850040177015 ()
- SPECT system application software
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 STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
STAR Apollo Mapping System
- Cardiac mapping system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution
- 00860009793507 ()
STAR Apollo Mapping System
- Cardiac mapping system application software
Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v.5
In Commercial Distribution
- 00860008443717 ()
- Diagnostic x-ray digital imaging system workstation application software
Optical Tracker Snap 11 0.090 IN
(previously known as Snap 1)
TrackX Technology, LLC
Snap 11
Not in Commercial Distribution
- 00860099000806 ()
TX-3-3036
- Diagnostic x-ray digital imaging system workstation application software
Disposable snap that snaps onto a Jamshidi for instrument tracking.
TrackX Technology, LLC
HANG-TEN SNAP
Not in Commercial Distribution
- 00860099000899 ()
- 00860099000882 ()
TX-3-3070
- Diagnostic x-ray digital imaging system workstation application software
TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution
- 00860099000837 ()
N/A
- Diagnostic x-ray digital imaging system workstation application software
Disposable snap that snaps onto a Jamshidi for instrument tracking.
Instrument Tracker .125 IN
(previously known as Snap 2 or 12)
TrackX Technology, LLC
T SNAP
Not in Commercial Distribution
- 00860099000813 ()
- 00860099000875 ()
TX-3-3038
- Diagnostic x-ray digital imaging system workstation application software
Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v5.15.5
In Commercial Distribution
- 00860290000391 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
XORAN TECHNOLOGIES LLC
v.6
In Commercial Distribution
- 00860290000384 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
XORAN TECHNOLOGIES LLC
5.2
In Commercial Distribution
- 00860290000322 ()
- Diagnostic x-ray digital imaging system workstation application software
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