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The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of the
patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/
Genesis Software Innovations LLC
2
In Commercial Distribution
- B973PREOPSHOULDER0 ()
- Image segmentation application software
No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution
- 04250406460007 ()
- Laboratory instrument/analyser application software IVD
No Description
MetaSystems Hard & Software GmbH
Medical Device Data System
In Commercial Distribution
- 04250406401000 ()
- Clinical management support software IVD
No Description
MetaSystems Hard & Software GmbH
Karyotyping System
In Commercial Distribution
- 04250406400003 ()
- Karyotyping cell-image analyser IVD
No Description
SWIFT HEALTH SYSTEMS INC.
Lower Patient Kit
In Commercial Distribution
- 00850018135139 ()
8121
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Digital Engancement
In Commercial Distribution
- 00850018135122 ()
8131
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Lower Fitting Kit
In Commercial Distribution
- 00850018135054 ()
85003
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Fitting Kit
In Commercial Distribution
- 00850018135047 ()
85000
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Upper Fitting Kit
In Commercial Distribution
- 00850018135030 ()
85002
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Upper Patient Kit
In Commercial Distribution
- 00850018135016 ()
8111
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Standard Patient Kit
In Commercial Distribution
- 00850018135009 ()
8101
- Orthodontic appliance/positioning tray kit
LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
Dental Imaging Technologies Corporation
594483
In Commercial Distribution
- 00693856000302 ()
594483
- CAD/CAM software
3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.
3shape A/S
2015-1
Not in Commercial Distribution
- 05902768365283 ()
- CAD/CAM software
The 3Shape Automate software is a web service for automatic design of crowns
3shape A/S
R1.2
In Commercial Distribution
- 05902729753821 ()
- Dental treatment application software
Dental treatment application software
3shape A/S
R1.0
In Commercial Distribution
- 05902729753555 ()
- Dental treatment application software
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution
- 05902729753487 ()
- Dental treatment application software
CAD/CAM software
3shape A/S
2017-1
Not in Commercial Distribution
- 05902729752510 ()
- CAD/CAM software
DentalSystem-backed web service for automatic designs of crowns.
3shape Trios A/S
R1.0
Not in Commercial Distribution
- 05902729753654 ()
- Dental treatment application software
Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution
- 05902729752954 ()
- Dental treatment application software
CAD/CAM software
3shape A/S
2018-1
Not in Commercial Distribution
- 05902729752787 ()
- CAD/CAM software
Orthodontic Software
Orchestrate 3d
1
In Commercial Distribution
- 00860008123404 ()
- Dental milling system, CAD/CAM, chairside
CEREC Ortho Software Version 2.1 Upgrade
SIRONA Dental Systems GmbH
6784495
In Commercial Distribution
- E27667844950 ()
- CAD/CAM software
CEREC Ortho Software Version 2.1
SIRONA Dental Systems GmbH
6748359
In Commercial Distribution
- E27667483590 ()
- CAD/CAM software
CEREC Ortho Software Version 2.0.0
SIRONA Dental Systems GmbH
6697986
In Commercial Distribution
- E27666979860 ()
- CAD/CAM software
CEREC Ortho Software Version 1.2.0
SIRONA Dental Systems GmbH
6611169
Not in Commercial Distribution
- E27666111690 ()
- CAD/CAM software
Orthodontic Software
PARK DENTAL RESEARCH CORP
O3D
In Commercial Distribution
- D769O3D0 ()
- CAD/CAM software
ClinCheck Pro 6
Align Technology, Inc.
SW-0000159
In Commercial Distribution
- 00816063021360 ()
- Orthodontic progressive aligner
LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
CARESTREAM DENTAL LLC
5944483
In Commercial Distribution
- 60192155944482 ()
5944483
- CAD/CAM software
CS MODEL+
CARESTREAM DENTAL LLC
CS Model+
Not in Commercial Distribution
- 60192155942716 ()
5942719
- CAD/CAM software
hi-PS (Programming Software) Fitting Software, Solo
INTRICON CORPORATION
hi-PS Solo
In Commercial Distribution
- 00858177007151 ()
23126
- Hearing aid wireless-fitting computer-aided set
SOFTWARE GE CLIENT SOFTWARE V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution
- 00840682123532 ()
- Cardiac catheterization monitoring system
- Cardiac electrophysiology analysis system
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-04-00-000
In Commercial Distribution
- 00817100020438 ()
- Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-03-04-000
In Commercial Distribution
- 00817100020421 ()
- Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution
- 00817100020414 ()
- Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution
- 00817100020186 ()
- Diagnostic x-ray digital imaging system workstation application software
No Description
OTODYNAMICS LIMITED
ILOv6
In Commercial Distribution
- 05060396170713 ()
- Otoacoustic emission system, line-powered
No Description
OTODYNAMICS LIMITED
EZ-Screen
In Commercial Distribution
- 05060396170706 ()
- Otoacoustic emission system, line-powered
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles
by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This
is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect
to naturalness and density) and the donor (taking care of the donor region).
The WAW Duo FUE System is composed of the following:
- The WAW Wireless Handpiece:
o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external
sleeve
o Connected via Bluetooth to the tablet
o Responsible for the rotation and oscillation movements of the punch (not included) for the
FUE,
- The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece:
o Cleanable (via autoclave)
o Connected via a wire to the pedal
o Responsible for the rotation and oscillation movements of the punch for the FUE,
- The WAW Pedal, responsible for activating the handpieces,
- The WAW Software, responsible for defining the parameters of functioning (rotation and
oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the
pedal (the Samsung tablet is supplied),
- The WAW Charging Station, intended to recharge the wireless handpiece and
- The External Sleeve Support Box, intended to sustain external parts of WAW Wireless
Handpiece and WAW Wired Handpiece during autoclave process.
- Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
0.1.35
In Commercial Distribution
- 05430003362068 ()
- Electrosurgical handpiece, reusable
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.
The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.
The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0811
In Commercial Distribution
- 05060484630051 ()
- Electrocardiography telemetric monitoring system
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.
The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.
The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution
- 05060484630044 ()
- Electrocardiography telemetric monitoring system
Actical Software Global
Respironics, Inc.
3.11
In Commercial Distribution
- 00606959021013 ()
1081738
- Kinesiology ambulatory recorder
Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution
- 00884838094895 ()
860292
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution
- 00884838000469 ()
860292
- Electrocardiographic ambulatory recorder
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution
- 00860001218275 ()
SFW-2012
- Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution
- 00858703006313 ()
- Bioelectrical signal analysis software
Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution
- 00856298006237 ()
101633
- Electrocardiographic long-term ambulatory recording analyser application software
Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution
- 00856298006213 ()
- Electrocardiographic long-term ambulatory recording analyser application software
Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution
- 00856264005776 ()
014300
- Retinal prosthesis system tester/clinical evaluator
Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution
- 00850154007086 ()
RS-0003
- Electroencephalography telemetric monitoring system
- Bioelectrical signal analysis software
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution
- 00850921007172 ()
- Extracorporeal ultrasound imaging transducer, hand-held