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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.
ABPM-05 (BP5)
Not in Commercial Distribution

  • 05999056500051 ()
-

  • Blood pressure ambulatory recorder
The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
ADVANCED
In Commercial Distribution

  • 05906874392027 ()


  • Eye movement analysis system
The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
PLUS
In Commercial Distribution

  • 05906874392010 ()


  • Eye movement analysis system
IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the placement of one or more implants based on an imported CBCT scan and optionally aligned with a loaded 3D surface scan. The implants are provided by a secured implant library. In addition Virtual Crowns can be used for optimized implant positioning under the esthetical aspect. Further a surgical guide for a guided surgery can be designed and exported for 3rd party fabrication based on the approved implant position. The use of the software requires to have the necessary expertise in implant dentistry.The IMPLANT STUDIO IPGS system must be operated by trained dental practitioners and dental technicians who are skilled in implant dentistry.The IMPLANT STUDIO IPGS software is to be used in general dentist clinics and dental laboratories.
3shape Medical A/S
2016-1
Not in Commercial Distribution

  • 05902768365306 ()


  • Dental treatment application software
3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
3shape A/S
R1.4
In Commercial Distribution

  • 05902729753845 ()


  • Dental treatment application 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
3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
3shape A/S
R1.3
In Commercial Distribution

  • 05902729753692 ()


  • Dental treatment application 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
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
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