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User interface in the patient's room
Vital Connect, Inc.
6100-03
In Commercial Distribution
- 00850490007382 ()
6100-03
- Electrocardiography telemetric monitoring system
User interface in the patient's room
Vital Connect, Inc.
6100-01
In Commercial Distribution
- 00850490007160 ()
6100-01
- 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
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
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
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00818
In Commercial Distribution
- 00873263008188 ()
C0258
- Neurophysiologic monitoring 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