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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.
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
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.
3.2
In Commercial Distribution
- 00606959059689 ()
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
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
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2189
In Commercial Distribution
- 14953170373807 ()
- 04953170373800 ()
N5400440
- Video capsule endoscopy system 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
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
No Description
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution
- 09321502075510 ()
P2121898
- Hearing aid wireless-fitting computer-aided set
No Description
LIFE TECHNOLOGIES CORPORATION
A54762
In Commercial Distribution
- 10190302018135 ()
- Laboratory instrument/analyser application software IVD
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
Standard Imaging StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation.
STANDARD IMAGING INC.
91340
In Commercial Distribution
- 00866562000281 ()
91340
- Accelerator system quality assurance device
Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.
STANDARD IMAGING INC.
91336
In Commercial Distribution
- 00866562000274 ()
91336
- Radiation therapy software
Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.
STANDARD IMAGING INC.
91330
In Commercial Distribution
- 00866562000267 ()
91330
- Radiation therapy software
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
STANDARD IMAGING INC.
v5
In Commercial Distribution
- 00866562000236 ()
91309
- Radiation therapy software
No Description
DRAEGER MEDICAL SYSTEMS, INC.
3736376
In Commercial Distribution
- 04048675777762 ()
- Bedside information system application software
No Description
DRAEGER MEDICAL SYSTEMS, INC.
3734718
In Commercial Distribution
- 04048675762256 ()
- Bedside information system application software
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS40545
In Commercial Distribution
- 04048675673408 ()
- Bedside information system application software
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
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
AVATAR MEDICAL Software V1 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
AVATAR MEDICAL
AMS V1
Not in Commercial Distribution
- 03770026095003 ()
- Radiology picture archiving and communication system workstation
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
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
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
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