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VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution
- 00868579000230 ()
- Radiological PACS software
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
No Description
ZOLL MANUFACTURING CORPORATION
Version 1.0
In Commercial Distribution
- 00855778005333 ()
- Electrocardiograph, professional, multichannel
The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300152
In Commercial Distribution
- 00860183001528 ()
- Stereotactic radiosurgery/radiation therapy linear accelerator system
The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300151
In Commercial Distribution
- 00860183001511 ()
- Stereotactic radiosurgery/radiation therapy linear accelerator system
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
In Commercial Distribution
- 00860013965204 ()
- Radiological PACS software
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
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.
6100-03
In Commercial Distribution
- 00850490007382 ()
6100-03
- Electrocardiography telemetric monitoring system