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Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
SUNI MEDICAL IMAGING, INC.
Advanced Imaging
In Commercial Distribution
- 00851067007033 ()
400-1243S
- General-purpose dental x-ray system application software
Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
SUNI MEDICAL IMAGING, INC.
Advanced Imaging
In Commercial Distribution
- 00851067007026 ()
400-1242S
- General-purpose dental x-ray system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution
- 00882916000530 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
2.1
In Commercial Distribution
- 00882916000523 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution
- 00882916000516 ()
v1.x and v2.0
- CT system application software
A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
APTERYX INC
2
In Commercial Distribution
- 00685031000047 ()
- General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software for XVWeb.
APTERYX INC
1
In Commercial Distribution
- 00685031000030 ()
- General-purpose dental x-ray system application software
The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS.
The software product integrates with the following components of the MPTS system:
• X-ray generator & tube assembly
• Amorphous silicon flat-panel detector
• Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient
The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs.
There are two defined methods of registration,
1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system.
2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis
EhmetDx LLC
v.1.x
In Commercial Distribution
- 00866854000401 ()
n/a
- CT system application software
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.
JPI HEALTHCARE. CO., LTD.
ExamVue PACS
In Commercial Distribution
- 08809413810174 ()
- Basic diagnostic x-ray system application software
The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
JPI HEALTHCARE. CO., LTD.
ExamVue DR
In Commercial Distribution
- 08809413810143 ()
- Basic diagnostic x-ray system application software
ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for digital radiography and use by radiologists and radiology technicians. ExamVue Duo saves the digital X-ray images acquired from the detector and process it to make the better image quality. The software also manages patient information, capture, and store diagnostic images in an internal database. It also supports DICOM 3.0 protocol which allows compatibility with the network programs such as the PACS system.
JPI HEALTHCARE. CO., LTD.
ExamVue Duo
In Commercial Distribution
- 08809413810679 ()
- Basic diagnostic x-ray system application software
The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
JPI HEALTHCARE. CO., LTD.
ExamVue DR
In Commercial Distribution
- 08809413810488 ()
- Basic diagnostic x-ray system application software
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.
JPI HEALTHCARE. CO., LTD.
ExamVue PACS
In Commercial Distribution
- 08809413810471 ()
- Basic diagnostic x-ray system application software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936889 ()
- Patient general health self-management software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936872 ()
- Patient general health self-management software
Prometra Clinician Prgrammer
Flowonix Medical, Inc.
13828
In Commercial Distribution
- 00810335020549 ()
- Infusion pump programmer
Prometra Clinician Programmer Print Tool
Flowonix Medical, Inc.
12840
In Commercial Distribution
- 00810335020266 ()
- Infusion pump programmer
The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller.
Flowonix Medical, Inc.
12861
In Commercial Distribution
- 00810335020181 ()
- Infusion pump programmer
The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.
Flowonix Medical, Inc.
12860
In Commercial Distribution
- 00810335020174 ()
- Infusion pump programmer
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).
Flowonix Medical, Inc.
12828
In Commercial Distribution
- 00810335020167 ()
- Infusion pump programmer
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.
Flowonix Medical, Inc.
11828
In Commercial Distribution
- 00810335020129 ()
- Infusion pump programmer
The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.
The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.
PULMONX CORPORATION
LIA-01-001
In Commercial Distribution
- 00811907031819 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution
- B745VASCUCAPA2 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution
- B745ELUCIDVIVOA3 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution
- B745A40 ()
- CT system application software
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SYS-1500
Not in Commercial Distribution
- 00815686020057 ()
SYS-1500
- Virtual bronchoscopic navigation PACS software
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SYS-0185
Not in Commercial Distribution
- 00815686020033 ()
SYS-0185
- Virtual bronchoscopic navigation PACS software
Spectral Color Overlay MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00195278630384 ()
5929649
- CT system application software
Spectral Bone Marrow MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00195278630377 ()
5929650
- CT system application software
Head Auto Views MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00195278629586 ()
5929651
- CT system application software
SWMD DLIR Application for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.2
In Commercial Distribution
- 00195278620453 ()
5928863
- CT system application software
MAR Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution
- 00195278303219 ()
- CT system application software
DLIR Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution
- 00195278303202 ()
- CT system application software
ASiR-V Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution
- 00195278303196 ()
- CT system application software
Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
Medos International Sàrl
91-4205US
Not in Commercial Distribution
- 10886704064947 ()
- 10886704071426 ()
914205US
- Infusion pump programmer
PROGRAMMER 8835 PERSONAL THERAPY
MEDTRONIC, INC.
8835
In Commercial Distribution
- 00613994338754 ()
- Infusion pump programmer
No Description
Siemens Healthcare GmbH
11665780
In Commercial Distribution
- 04056869996172 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11664807
In Commercial Distribution
- 04056869994536 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546460
In Commercial Distribution
- 04056869966922 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11665409
Not in Commercial Distribution
- 04056869964331 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11583325
In Commercial Distribution
- 04056869297293 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11583324
In Commercial Distribution
- 04056869297286 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11583323
In Commercial Distribution
- 04056869297279 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546430
In Commercial Distribution
- 04056869287416 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546418
In Commercial Distribution
- 04056869287393 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546417
In Commercial Distribution
- 04056869287386 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546336
In Commercial Distribution
- 04056869267463 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546318
In Commercial Distribution
- 04056869267425 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546307
In Commercial Distribution
- 04056869267340 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546136
In Commercial Distribution
- 04056869252230 ()
- CT system application software