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Software version for Amicus Separator.
Fresenius Kabi AG
5.12
In Commercial Distribution
- 04086000101660 ()
- Apheresis system
Software version for Amicus Separator.
Fresenius Kabi AG
5.121
In Commercial Distribution
- 04086000101653 ()
- Apheresis system
Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution
- 04086000101516 ()
- Apheresis system
Care Orchestrator Clinical Management Data Software
Respironics, Inc.
1.13
In Commercial Distribution
- 00606959050730 ()
1126366
- Medical equipment clinical data interfacing software
No Description
KONICA MINOLTA, INC.
AEVM
In Commercial Distribution
- 04560141951433 ()
- Basic diagnostic x-ray system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution
- 14953170373760 ()
- 04953170373763 ()
N5400340
- Video capsule endoscopy system application software
No Description
CANON MEDICAL SYSTEMS CORPORATION
VSTP-002A
In Commercial Distribution
- 04987670105005 ()
- Radiological PACS 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
Omniscient Neurotechnology Pty Ltd (o8t)
2.1
In Commercial Distribution
- 09358140000055 ()
SCI0006
- Radiological PACS software
US & International
DEXIS LLC
9
In Commercial Distribution
- EKAV101034110 ()
PLU349
- Radiology information system application software