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VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution
- 03573026619060 ()
- Microorganism identification/antimicrobial-susceptibility analyser IVD
No Description
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution
- 09321502075510 ()
P2121898
- Hearing aid wireless-fitting computer-aided set
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution
- 00843152104000 ()
SW-1
- Electromagnetic surgical navigation device tracking 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
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.
480 Channel
In Commercial Distribution
- 00850011306888 ()
36-0301-0044
- Electroencephalographic monitoring system
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.
416 Channel
In Commercial Distribution
- 00850011306864 ()
36-0301-0042
- Electroencephalographic monitoring system
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.
352 Channel
In Commercial Distribution
- 00850011306840 ()
36-0301-0040
- Electroencephalographic monitoring system
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.
320 Channel
In Commercial Distribution
- 00850011306833 ()
36-0301-0039
- Electroencephalographic monitoring system
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.
288 Channel
In Commercial Distribution
- 00850011306826 ()
36-0301-0038
- Electroencephalographic monitoring system
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.
256 Channel
In Commercial Distribution
- 00850011306819 ()
36-0301-0037
- Electroencephalographic monitoring system
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.
224 Channel
In Commercial Distribution
- 00850011306802 ()
36-0301-0036
- Electroencephalographic monitoring system
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.
192 Channel
In Commercial Distribution
- 00850011306796 ()
36-0301-0035
- Electroencephalographic monitoring system
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.
160 Channel
In Commercial Distribution
- 00850011306789 ()
36-0301-0034
- Electroencephalographic monitoring system
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.
128 Channel
In Commercial Distribution
- 00850011306772 ()
36-0301-0033
- Electroencephalographic monitoring system
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.
96 Channel
In Commercial Distribution
- 00850011306765 ()
36-0301-0032
- Electroencephalographic monitoring system
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.
64 channel
In Commercial Distribution
- 00850011306758 ()
36-0301-0031
- Electroencephalographic monitoring system
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
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.
448 Channel
In Commercial Distribution
- 00850011306871 ()
36-0301-0043
- Electroencephalographic monitoring system
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.
384 Channel
In Commercial Distribution
- 00850011306857 ()
36-0301-0041
- Electroencephalographic monitoring system
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