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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
No Description
ergoline GmbH
161801
In Commercial Distribution
- 04059358001838 ()
- Cardiopulmonary parameter spot-check measurement software
syngo Application Software VE3
Siemens Healthcare GmbH
30000266
In Commercial Distribution
- 04056869964546 ()
- Basic diagnostic x-ray system application software
syngo Application Software VE4
Siemens Healthcare GmbH
30000267
In Commercial Distribution
- 04056869964539 ()
- Basic diagnostic x-ray system application software
syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Siemens Healthcare GmbH
11328180
In Commercial Distribution
- 04056869262567 ()
- Basic diagnostic x-ray system application software
syngo Application Software VD2
Siemens Healthcare GmbH
10849231
In Commercial Distribution
- 04056869050874 ()
- Basic diagnostic x-ray system application software
syngo Application Software VD1
Siemens Healthcare GmbH
10849124
In Commercial Distribution
- 04056869012902 ()
- Basic diagnostic x-ray system application software
syngo Application Software VE2
Siemens Healthcare GmbH
11327667
In Commercial Distribution
- 04056869124162 ()
- Basic diagnostic x-ray system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149926
Not in Commercial Distribution
- 04056869006840 ()
- Radiological PACS software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10855671
Not in Commercial Distribution
- 04056869001067 ()
- Radiological PACS software
B125/B105 V1.5 SW PACK (USB) - MD
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V1.5
Not in Commercial Distribution
- 00840682141291 ()
- General-purpose multi-parameter bedside monitor
The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions.
LUMINEX CORPORATION
CN-SW47
In Commercial Distribution
- 00840487100448 ()
- Laboratory instrument/analyser application software IVD
No Description
Gynesonics, Inc.
SW-002
In Commercial Distribution
- 10817929020340 ()
SW-002
- Ultrasound-guided radio-frequency ablation system software
A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
MASTERLINK LLC
1
In Commercial Distribution
- D875403051 ()
- General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
MASTERLINK LLC
1
In Commercial Distribution
- D875400101 ()
- General-purpose dental x-ray system application software
No Description
CANON MEDICAL SYSTEMS CORPORATION
VSTP-002A
In Commercial Distribution
- 04987670105005 ()
- Radiological PACS software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution
- 14953170373760 ()
- 04953170373763 ()
N5400340
- Video capsule endoscopy system application software
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
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
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
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
SFW 9735911 STEALTH S8 STEREOTAXY
MEDTRONIC NAVIGATION, INC.
9735911
In Commercial Distribution
- 00643169878211 ()
- Neurological stereotactic surgery system
SFW 9735910 STEALTH S8 DBS
MEDTRONIC NAVIGATION, INC.
9735910
In Commercial Distribution
- 00643169878204 ()
- Neurological stereotactic surgery system
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution
- 00643169865341 ()
- Multi-purpose stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution
- 00643169838987 ()
- Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution
- 00643169838970 ()
- Neurological stereotactic surgery system
SW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution
- 00643169838963 ()
- Neurological stereotactic surgery 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.
NAVIS-EX
In Commercial Distribution
- 04987669100523 ()
- Eye anterior segment analyser software
- Posterior eye segment analyser software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT acquisition software
In Commercial Distribution
- 05056190500757 ()
MapRT
- Radiation therapy software
AlignRT 7.3 (software) used on AlignRT Plus systems
VISION RT LIMITED
AlignRT 7.3 (software)
In Commercial Distribution
- 05056190500726 ()
AlignRT 7.3 (software)
- Radiological video camera patient positioning/tracking system
No Description
KEELER LIMITED
3020-P-5079
In Commercial Distribution
- 05055272715744 ()
- Ophthalmic examination slit lamp
SFW KIT 9735916 S8 CRANIAL PLAN STATION
MEDTRONIC NAVIGATION, INC.
9735916
In Commercial Distribution
- 00643169931329 ()
- Neurological stereotactic surgery system
SFW KIT 9735921 S8 DBS STEREOTX
MEDTRONIC NAVIGATION, INC.
9735921
In Commercial Distribution
- 00643169921917 ()
- Neurological stereotactic surgery system
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
2.1
In Commercial Distribution
- 09358140000055 ()
SCI0006
- Radiological PACS software
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0671-0101-2
In Commercial Distribution
- 04049016151012 ()
- Laboratory instrument/analyser application software IVD
No Description
Brainlab AG
3.0
Not in Commercial Distribution
- 04056481138790 ()
26615-01
- Robotic surgical navigation system
No Description
Brainlab AG
3.0
Not in Commercial Distribution
- 04056481138783 ()
26614-01
- Robotic surgical navigation system
No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution
- 04049539070302 ()
- Operating room audiovisual data/device management system
Care Orchestrator Clinical Management Data Software
Respironics, Inc.
1.13
In Commercial Distribution
- 00606959050730 ()
1126366
- Medical equipment clinical data interfacing software
The Alignment Software Cranial is a software which enables navigated surgery. It is intended to support the surgeon in planning and reaching a pre-defined position through manual or semi-automated navigation of surgical instruments based on information obtained from optical tracking devices.
Brainlab AG
2.0
In Commercial Distribution
- 04056481144487 ()
- Electromagnetic/optical surgical navigation device tracking system
The Alignment Software Spine supports the surgeon in reaching a pre-defined position by controlling and monitoring the movement of the Cirq Robotic Alignment Module.
Brainlab AG
2.0
In Commercial Distribution
- 04056481144470 ()
- Electromagnetic/optical surgical navigation device tracking system
No Description
Brainlab AG
3.5
In Commercial Distribution
- 04056481140687 ()
- Robotic surgical navigation system
No Description
Brainlab AG
3.5
Not in Commercial Distribution
- 04056481140663 ()
- Robotic surgical navigation system
D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integrating with the client information system and patient EMR (HL7) and PACS/VNA (DICOM).
D-Scope Systems
6
In Commercial Distribution
- 00860009377615 ()
- Endoscopic video image processing unit
D-Scope Systems workstation software is a hardware-agnostic application for HD-quality medical video and image recording in clinical and OR settings. The user interface allows capture, marking, storage and sharing of files that has integration capability with patient EMR (HL7) and PACS/VNA (DICOM).
The application and its browser allow access to a secure space within the client's network that facilitates remote and local file review, referrals and consultations with a HIPAA conformant logon authorization.
Intended functions include medical process automation: procedural steps, population of patient demographic data, and management of active medical media from scheduling through discharge.
D-Scope Systems
6
In Commercial Distribution
- 00860009377608 ()
- Endoscopic video image processing unit