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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.
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
ZOLL MANUFACTURING CORPORATION
Version 1.0
In Commercial Distribution
- 00855778005333 ()
- Electrocardiograph, professional, multichannel
E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities.
E-LINK is available in English, Chinese, German and Spanish.
BIOMETRICS LIMITED
16xx-xxx-xxxx
In Commercial Distribution
- 05060481690454 ()
- Biomechanical function analysis/rehabilitation software
No Description
OTODYNAMICS LIMITED
OTOLINK
In Commercial Distribution
- 05060396170591 ()
- Evoked-potential audiometer
- Otoacoustic emission system, battery-powered
User interface in the patient's room
Vital Connect, Inc.
6100-01
In Commercial Distribution
- 00850490007160 ()
6100-01
- Electrocardiography telemetric monitoring system
User interface in the patient's room
Vital Connect, Inc.
6100-03
In Commercial Distribution
- 00850490007382 ()
6100-03
- Electrocardiography telemetric monitoring system
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005212 ()
DS0244, D70130
- Basic diagnostic x-ray system application software
No Description
INTERSON CORP
x.x
In Commercial Distribution
- 00850921007202 ()
- General-purpose ultrasound imaging system
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
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
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
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
The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300152
In Commercial Distribution
- 00860183001528 ()
- Stereotactic radiosurgery/radiation therapy linear accelerator system
The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300151
In Commercial Distribution
- 00860183001511 ()
- Stereotactic radiosurgery/radiation therapy linear accelerator system
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
Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.
The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor.
OMNYX, LLC
2.4
In Commercial Distribution
- 00860007120206 ()
- Pathology information system application software
A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo.
Megin Oy
SW23380N
In Commercial Distribution
- 06430056480022 ()
- Electroencephalograph
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
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
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
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
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
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
271627
In Commercial Distribution
- 03661489716270 ()
- Orthopaedic/craniofacial implantation planning software
Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.
EB NEURO SPA
B8640053000
In Commercial Distribution
- 08056446900642 ()
- Bioelectrical signal analysis software
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
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
EMAG software (virtual) version 1.4 also called SP4
BIOMERIEUX SA
1.4
In Commercial Distribution
- 03573026635046 ()
- Nucleic acid sample preparation instrument IVD