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The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and
recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing
an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring
equipment. This feature allows patients to comply with exercise prescriptions while exercising at a
medical/rehabilitation facility near their home, or by returning to the primary medical facility to
participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program
Management module that prints a variety of reports.
SCOTTCARE CORPORATION, THE
TeleRehab Software File Manager
In Commercial Distribution
- 00856298006244 ()
101601
- Electrocardiography telemetric monitoring system
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
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00818
In Commercial Distribution
- 00873263008188 ()
C0258
- Neurophysiologic monitoring system
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00808
Not in Commercial Distribution
- 00873263008089 ()
C0258
- Neurological stereotactic surgery system
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
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
Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF002
Not in Commercial Distribution
- 00850013007295 ()
ELF002
- Audiometric/hearing device software
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
512 Channel
In Commercial Distribution
- 00850011306895 ()
36-0301-0045
- Electroencephalographic monitoring system