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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.
32 channel
In Commercial Distribution
- 00850011306741 ()
36-0301-0030
- Electroencephalographic monitoring system
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
This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package.
Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vitrea Software Package.
CANON MEDICAL SYSTEMS CORPORATION
VSTP-001A
In Commercial Distribution
- 04987670102493 ()
- Radiology DICOM image processing application software
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client
PC.
NIDEK CO.,LTD.
1.12
In Commercial Distribution
- 04987669200636 ()
- Eye anterior segment analyser software
- Posterior eye segment analyser software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2189
In Commercial Distribution
- 14953170373807 ()
- 04953170373800 ()
N5400440
- Video capsule endoscopy system application software
Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.
The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor.
OMNYX, LLC
2.4
In Commercial Distribution
- 00860007120206 ()
- Pathology information system application software
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
VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution
- 00868579000230 ()
- Radiological PACS software
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