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The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005212 ()
DS0244, D70130
- Basic diagnostic x-ray system application software
E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities.
E-LINK is available in English, Chinese, German and Spanish.
BIOMETRICS LIMITED
16xx-xxx-xxxx
In Commercial Distribution
- 05060481690454 ()
- Biomechanical function analysis/rehabilitation software
No Description
OTODYNAMICS LIMITED
OTOLINK
In Commercial Distribution
- 05060396170591 ()
- Evoked-potential audiometer
- Otoacoustic emission system, battery-powered
No Description
INTERSON CORP
x.x
In Commercial Distribution
- 00850921007202 ()
- General-purpose ultrasound imaging system
User interface in the patient's room
Vital Connect, Inc.
6100-01
In Commercial Distribution
- 00850490007160 ()
6100-01
- Electrocardiography telemetric monitoring system
User interface in the patient's room
Vital Connect, Inc.
6100-03
In Commercial Distribution
- 00850490007382 ()
6100-03
- Electrocardiography telemetric monitoring system
No Description
MEDSPIRA, LLC
RMD-002-001
In Commercial Distribution
- 00851607003211 ()
- Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-003
In Commercial Distribution
- 00851607003204 ()
- Manometric gastrointestinal motility analysis system
A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo.
Megin Oy
SW23380N
In Commercial Distribution
- 06430056480022 ()
- Electroencephalograph
Standard Imaging StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation.
STANDARD IMAGING INC.
91340
In Commercial Distribution
- 00866562000281 ()
91340
- Accelerator system quality assurance device
Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.
STANDARD IMAGING INC.
91336
In Commercial Distribution
- 00866562000274 ()
91336
- Radiation therapy software
Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.
STANDARD IMAGING INC.
91330
In Commercial Distribution
- 00866562000267 ()
91330
- Radiation therapy software
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
STANDARD IMAGING INC.
v5
In Commercial Distribution
- 00866562000236 ()
91309
- Radiation therapy software
No Description
Philips Ultrasound LLC
989605496481
In Commercial Distribution
- 00884838091672 ()
- Radiological PACS software
No Description
Philips Ultrasound LLC
989605492681
In Commercial Distribution
- 00884838090736 ()
- Radiological PACS software
No Description
Philips Ultrasound LLC
989605465051
In Commercial Distribution
- 00884838084322 ()
- Radiological PACS software
BrainSpec Core™ Software is a web-based software platform that allows for the interpretation of magnetic spectroscopy data to display relative levels of brain metabolites.
BrainSpec Inc.
BrainSpec Core™ Software
Not in Commercial Distribution
- 00198715251623 ()
- Radiological PACS software
EMAG software (virtual) version 1.4 also called SP4
BIOMERIEUX SA
1.4
In Commercial Distribution
- 03573026635046 ()
- Nucleic acid sample preparation instrument IVD
Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.
EB NEURO SPA
B8640053000
In Commercial Distribution
- 08056446900642 ()
- Bioelectrical signal analysis software
No Description
M2S, INC.
4.x
Not in Commercial Distribution
- B119PREVIEW0 ()
- Radiology information system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution
- B118314170 ()
- Ultrasound imaging system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution
- B118314160 ()
- Ultrasound imaging system application software
v. 1.2
Orthosoft Inc
302.4018
In Commercial Distribution
- 00889024647046 ()
302.4018
- Radiology DICOM image processing application software
v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution
- 00889024647039 ()
302.4018
- Radiology DICOM image processing application software
v. 1.0
Orthosoft Inc
302.4018
In Commercial Distribution
- 00889024585393 ()
302.4018
- Radiology DICOM image processing application software
No Description
Orthosoft Inc
20-8020-130-01
In Commercial Distribution
- 00889024511330 ()
20-8020-130-01
- Robotic surgical navigation system application software
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution
- B690MS10 ()
- Electrocardiographic long-term ambulatory recording analyser application software
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-01-00-000
In Commercial Distribution
- 00817100020407 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M020101
In Commercial Distribution
- 00817020020785 ()
- Visual-reinforcement-audiometry reward system
Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions
Sensimed SA
V3
In Commercial Distribution
- 07640153470157 ()
ST8000
- Ocular volume ambulatory recording system software