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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.
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.
32 channel
In Commercial Distribution
- 00850011306741 ()
36-0301-0030
- Electroencephalographic monitoring system
No Description
OTODYNAMICS LIMITED
OTOLINK
In Commercial Distribution
- 05060396170591 ()
- Evoked-potential audiometer
- Otoacoustic emission system, battery-powered
No Description
LIFE TECHNOLOGIES CORPORATION
A54762
In Commercial Distribution
- 10190302018135 ()
- Laboratory instrument/analyser application software IVD
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
Care Orchestrator Essence, Clinical data collection management information system application software
Respironics, Inc.
3.3
In Commercial Distribution
- 00606959060449 ()
1135709
- Medical equipment clinical data interfacing software
Care Orchestrator Essence, Clinical data collection management information system application software
Respironics, Inc.
3.1
In Commercial Distribution
- 00606959059085 ()
1135709
- Medical equipment clinical data interfacing software
Care Orchestrator Essence, Clinical data collection management information system application software
Respironics, Inc.
3.2
In Commercial Distribution
- 00606959059689 ()
1135709
- Medical equipment clinical data interfacing software
No Description
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution
- 09321502075510 ()
P2121898
- Hearing aid wireless-fitting computer-aided set
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2189
In Commercial Distribution
- 14953170373807 ()
- 04953170373800 ()
N5400440
- Video capsule endoscopy system application 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
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution
- 00897826002178 ()
- Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution
- 00897826002161 ()
- Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
1.03.03-U
In Commercial Distribution
- 00897826002154 ()
- Ophthalmic ultrasound imaging system
No Description
Brainlab AG
3.1
Not in Commercial Distribution
- 04056481000745 ()
22082
- Robotic surgical navigation system
No Description
Brainlab AG
3.2
Not in Commercial Distribution
- 04056481000738 ()
22084
- Robotic surgical navigation system
No Description
Brainlab AG
3.2
Not in Commercial Distribution
- 04056481000509 ()
22082-01A
- Robotic surgical navigation system
No Description
Brainlab AG
1,0
In Commercial Distribution
- 04056481141837 ()
- Robotic surgical navigation system
No Description
Brainlab AG
1.0
Not in Commercial Distribution
- 04056481140311 ()
22265-04
- Robotic surgical navigation system
No Description
Orthosoft Inc
20-8020-130-01
In Commercial Distribution
- 00889024511330 ()
20-8020-130-01
- Robotic surgical navigation system application software
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution
- B690MS10 ()
- Electrocardiographic long-term ambulatory recording analyser application software
v. 1.0
Orthosoft Inc
302.4018
In Commercial Distribution
- 00889024585393 ()
302.4018
- Radiology DICOM image processing application software
v. 1.2
Orthosoft Inc
302.4018
In Commercial Distribution
- 00889024647046 ()
302.4018
- Radiology DICOM image processing application software
v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution
- 00889024647039 ()
302.4018
- Radiology DICOM image processing application software
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
271627
In Commercial Distribution
- 03661489716270 ()
- Orthopaedic/craniofacial implantation planning software
No Description
HELENA LABORATORIES CORPORATION
1691000
In Commercial Distribution
- M52516910000 ()
- Densitometry analyser IVD
No Description
NXSTAGE MEDICAL, INC.
NX1000-16-F
In Commercial Distribution
- M535NX100016F0 ()
- Haemodialysis system, institutional/home-use
No Description
NXSTAGE MEDICAL, INC.
NX1000-10-G
In Commercial Distribution
- M535NX100010G0 ()
- Haemodialysis system, institutional/home-use
No Description
NXSTAGE MEDICAL, INC.
NX1000-10-F
In Commercial Distribution
- M535NX100010F0 ()
- Haemodialysis system, institutional/home-use
No Description
NXSTAGE MEDICAL, INC.
NX1000-10-E
In Commercial Distribution
- M535NX100010E0 ()
- Haemodialysis system, institutional/home-use
The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:
- Endoanal ultrasound (trans-rectal ultrasound / echography)
- Anoscopy exams
- Manometry exams
THD SPA
THD Procto Software
In Commercial Distribution
- 08033737713037 ()
760004
- Ultrasound imaging system application software
EMAG software (virtual) version 1.4 also called SP4
BIOMERIEUX SA
1.4
In Commercial Distribution
- 03573026635046 ()
- Nucleic acid sample preparation instrument IVD
EMAG software (virtual) version 1.3 also called SP3
BIOMERIEUX SA
1.3
In Commercial Distribution
- 03573026613358 ()
- Nucleic acid sample preparation instrument IVD