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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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LINEAR ARRAY PROBE
CANON MEDICAL SYSTEMS CORPORATION
PEF-704LA
In Commercial Distribution

  • 04987670000522 ()


  • Surgical ultrasound imaging transducer
CW DOPPLER PENCIL TRANSDUCER
CANON MEDICAL SYSTEMS CORPORATION
PC-50V
In Commercial Distribution

  • 04987670000492 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
CW DOPPLER PENCIL TRANSDUCER
CANON MEDICAL SYSTEMS CORPORATION
PC-20M
In Commercial Distribution

  • 04987670000485 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
DOPPLER PENCIL PROBE
CANON MEDICAL SYSTEMS CORPORATION
PC-19M
In Commercial Distribution

  • 04987670000478 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.
NIDEK CO.,LTD.
1.1
In Commercial Distribution

  • 04987669607350 ()


  • Eye anterior segment analyser software
The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as corneal curvature radius and axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669203651 ()
32NNNN

  • Ophthalmic examination slit lamp
  • Bench-top keratometer
The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as corneal curvature radius and axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669203477 ()
39NNNN

  • Ophthalmic examination slit lamp
  • Bench-top keratometer
The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to handle the AL-Scan data within NAVIS-EX. This function is added to the computer as a plug-in for NAVISEX. The measured value data and waveform can be displayed, the IOL power can be calculated, and the toric lens assist data can be created. The AL-Scan data is imported to NAVIS-EX using separate software, Data Acquisition Service.
NIDEK CO.,LTD.
1.3
In Commercial Distribution

  • 04987669200773 ()


  • Eye anterior segment analyser 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.
1.12
In Commercial Distribution

  • 04987669200636 ()


  • Eye anterior segment analyser software
  • Posterior eye segment analyser software
It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.
NIDEK CO.,LTD.
14611-0006
In Commercial Distribution

  • 04987669200117 ()


  • Ophthalmic ultrasound imaging system
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