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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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Leica Biosystems RDX QUICKSTOR 8863 USB3
Leica Biosystems Richmond, Inc.
23RDX8863
Not in Commercial Distribution

  • 00849832013235 ()

  • Device Size Text, specify:


  • Digital storage media
Leica Biosystems Cytovision Removable Archive Device
Leica Biosystems Richmond, Inc.
23STR003XXX001
Not in Commercial Distribution

  • 00849832005155 ()

  • Device Size Text, specify:


  • Digital storage media
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 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
Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX. In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX.
NIDEK CO.,LTD.
1.0
In Commercial Distribution

  • 04987669101421 ()


  • Eye anterior segment analyser software
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.
1.1
In Commercial Distribution

  • 04987669101360 ()


  • Eye anterior segment analyser software
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

  • 04987669101353 ()


  • Eye anterior segment analyser software
MEDICAP USB 300
PENTAX OF AMERICA, INC.
9139HD
In Commercial Distribution

  • 04961333242184 ()


  • Digital storage media
MEDICAP USB200 DIGITAL REC
PENTAX OF AMERICA, INC.
9139
In Commercial Distribution

  • 04961333240654 ()


  • Digital storage media
KEYBOARD, SUPER MINI USB
PENTAX OF AMERICA, INC.
1111-1871
In Commercial Distribution

  • 04961333241835 ()


  • Digital storage media
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