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Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1061945
In Commercial Distribution
- 00811376030023 ()
NA
- Linear accelerator system
No Description
Biomet Orthopedics, LLC
CG100
Not in Commercial Distribution
- 00880304992863 ()
CG100
- Orthopaedic/craniofacial implantation planning software
No Description
Philips Ultrasound LLC
Release 10.7
In Commercial Distribution
- 00884838070837 ()
- Radiological PACS software
The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
Wallac Oy
5020-1000
In Commercial Distribution
- 06438147373901 ()
5020-1000
- Human genomic analysis interpretive software IVD
3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Adaptiiv Medical Technologies Inc
v3.0.0
In Commercial Distribution
- 00860007402302 ()
- Radiation therapy software
SFW KIT 9735916 S8 CRANIAL PLAN STATION
MEDTRONIC NAVIGATION, INC.
9735916
In Commercial Distribution
- 00643169931329 ()
- Neurological stereotactic surgery system
SFW 9735911 STEALTH S8 STEREOTAXY
MEDTRONIC NAVIGATION, INC.
9735911
In Commercial Distribution
- 00643169878211 ()
- 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 9735921 S8 DBS STEREOTX
MEDTRONIC NAVIGATION, INC.
9735921
In Commercial Distribution
- 00643169921917 ()
- Neurological stereotactic surgery system
SFW 9735910 STEALTH S8 DBS
MEDTRONIC NAVIGATION, INC.
9735910
In Commercial Distribution
- 00643169878204 ()
- Neurological stereotactic surgery system
No Description
ORAMETRIX, INC.
7.6
In Commercial Distribution
- 00856379007085 ()
- CAD/CAM software
Software used by the clinician to interface with the WalkAide unit. This allows data collection,
analysis and parameter modification in order to correctly time the applied stimulation to the
user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution
- 00858184006130 ()
- Gait-enhancement electrical stimulation system, external
Version 15.0
Philips Ultrasound LLC
989606710071
In Commercial Distribution
- 00884838098220 ()
- Radiological PACS software
No Description
Philips Ultrasound LLC
Release 10.8.5
In Commercial Distribution
- 00884838086616 ()
- Radiological PACS software
No Description
Philips Ultrasound LLC
Release 3.8
In Commercial Distribution
- 00884838083509 ()
- Radiological PACS software
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution
- 00862696000289 ()
- Laboratory instrument/analyser application software IVD
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution
- 00865435000311 ()
SCIII SW
- Heater/cooler system tester kit
VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
ORTHO KINEMATICS, INC.
3
In Commercial Distribution
- 00868579000223 ()
- Radiological PACS software
No Description
ORTHO KINEMATICS, INC.
2.3
In Commercial Distribution
- 00868579000216 ()
- Radiological PACS software
No Description
Archform Inc.
Various
In Commercial Distribution
- 00860012168521 ()
2
- CAD/CAM software
No Description
Virtual Vision Health
3.2.0
In Commercial Distribution
- 00860010709795 ()
VV-021
- Perimeter, automatic
No Description
Virtual Vision Health
3.1.0
In Commercial Distribution
- 00860010709788 ()
- Perimeter, automatic
No Description
Virtual Vision Health
3.0.0
In Commercial Distribution
- 00860010709757 ()
- Perimeter, automatic
No Description
Virtual Vision Health
2.7.0
In Commercial Distribution
- 00860010709740 ()
- Perimeter, automatic
No Description
Virtual Vision Health
2.6.0
In Commercial Distribution
- 00860010709733 ()
- Perimeter, automatic
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
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
Philips Ultrasound LLC
Release 10.5
In Commercial Distribution
- 00884838059788 ()
- Radiological PACS 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
VIEWRAY INCORPORATED
A3i
In Commercial Distribution
- 00850036816027 ()
- Linear accelerator system
- Stereotactic teletherapy radionuclide system, MRI-imaging
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
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
KEELER LIMITED
3020-P-5079
In Commercial Distribution
- 05055272715744 ()
- Ophthalmic examination slit lamp
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