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No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution
- 04049539070302 ()
- Operating room audiovisual data/device management system
Software version for Amicus Separator
Fresenius Kabi AG
6.0
In Commercial Distribution
- 04086000101912 ()
- Apheresis system
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
Animal
DEXIS LLC
9
In Commercial Distribution
- EKAV101034090 ()
PLU235
- Radiology information system application software
Forensic
DEXIS LLC
9
In Commercial Distribution
- EKAV101034080 ()
PLU236
- Radiology information system application software
Enterprise
DEXIS LLC
9
In Commercial Distribution
- EKAV101034120 ()
PLU238
- Radiology information 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.
NAVIS-EX
In Commercial Distribution
- 04987669100523 ()
- Eye anterior segment analyser software
- Posterior eye segment analyser software
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.7
In Commercial Distribution
- 00850005944508 ()
83-00054-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.8
In Commercial Distribution
- 00850005944355 ()
83-00093-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.6
In Commercial Distribution
- 00850005944119 ()
83-00054-000
- Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution
- 00850005944089 ()
83-00054-000
- Magnetic neural stimulation system
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution
- 00850013007417 ()
ELF003
- Audiometric/hearing device software
No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution
- 07613327581843 ()
05000-VRSE
- Arthroplasty force sensor display unit
Cranial Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81042
In Commercial Distribution
- 07613327538328 ()
81-81042
- Electromagnetic/optical surgical navigation device tracking system
Cranial Guidance Enable
Stryker Leibinger GmbH & Co. KG
6000-670-300
In Commercial Distribution
- 07613327538410 ()
6000-670-300
- Electromagnetic/optical surgical navigation device tracking system
No Description
Orthosoft Inc
20-8060-400-01
In Commercial Distribution
- 00887868525681 ()
20-8060-400-01
- Orthopaedic prosthesis implantation positioning instrument, reusable
Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution
- 60889971045072 ()
1045079
- General-purpose dental x-ray system application software
No Description
Bio/Data Corporation
107153
In Commercial Distribution
- G0561071530 ()
107053
- Platelet aggregation analyser IVD
Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test.
Aktina Corp.
80-800
In Commercial Distribution
- B3658080000 ()
- Accelerator system quality assurance device
No Description
Aktina Corp.
50-135
In Commercial Distribution
- B365501350 ()
- Stereotactic system application software
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0010
Not in Commercial Distribution
- 00815686021085 ()
SFT-0010
- Virtual bronchoscopic navigation PACS software
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0004
Not in Commercial Distribution
- 00815686021061 ()
SFT-0004
- Electromagnetic surgical navigation device tracking system
No Description
CAScination AG
4.1
In Commercial Distribution
- 07616962000250 ()
20016
- Radiology picture archiving and communication system workstation
Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution
- B277292U400CD2 ()
- B277292U400CD1 ()
- B277292U400CD0 ()
292-U400CD
- Bioelectrical body composition analyser
No Description
MEDTRAK VNG, INC.
M917081
In Commercial Distribution
- B292M9170810 ()
- Eye movement analysis system
No Description
Institut Straumann AG
1
Not in Commercial Distribution
- 07630031738820 ()
019.2033
- Dental milling system, CAD/CAM, chairside
No Description
Institut Straumann AG
1
Not in Commercial Distribution
- 07630031738813 ()
019.2032
- Dental milling system, CAD/CAM, laboratory
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0007
Not in Commercial Distribution
- 00815686021078 ()
SFT-0007
- Virtual bronchoscopic navigation PACS software
No Description
M DIALYSIS INC.
English
In Commercial Distribution
- 07332699000751 ()
8001027
- Bedside information system
No Description
Thought Technology Ltd.
SA7900
In Commercial Distribution
- 07540191000449 ()
- Psychophysiological biofeedback system
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
2.2
In Commercial Distribution
- 09358140000062 ()
SCI0006
- Radiological PACS software