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No Description
VIEWRAY INCORPORATED
A3i
In Commercial Distribution
- 00850036816027 ()
- Linear accelerator system
- Stereotactic teletherapy radionuclide system, MRI-imaging
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution
- 00850013007417 ()
ELF003
- Audiometric/hearing device software
The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds
and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of
suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal
sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS
duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify
other arrhythmias.
It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software
are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
Eko Devices, Inc.
EAS
In Commercial Distribution
- 00850010298030 ()
- Cardiopulmonary physiological parameter analysis software
No Description
KEELER LIMITED
3020-P-5079
In Commercial Distribution
- 05055272715744 ()
- Ophthalmic examination slit lamp
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.7
In Commercial Distribution
- 00850005944508 ()
83-00054-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.8
In Commercial Distribution
- 00850005944355 ()
83-00093-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.6
In Commercial Distribution
- 00850005944119 ()
83-00054-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution
- 00850005944089 ()
83-00054-000
- Magnetic neural stimulation system
No Description
KONICA MINOLTA, INC.
AEVM
In Commercial Distribution
- 04560141951433 ()
- Basic diagnostic x-ray system application software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
2.1
In Commercial Distribution
- 09358140000055 ()
SCI0006
- Radiological PACS software