DICOM VIDEO

Digitizer, Image, Radiological

BAR CODE COMPUTER LTD

The following data is part of a premarket notification filed by Bar Code Computer Ltd with the FDA for Dicom Video.

Pre-market Notification Details

Device IDK132183
510k NumberK132183
Device Name:DICOM VIDEO
ClassificationDigitizer, Image, Radiological
Applicant BAR CODE COMPUTER LTD 6 SIRENI Haifa,  IL 32972
ContactDan Laor
CorrespondentDan Laor
BAR CODE COMPUTER LTD 6 SIRENI Haifa,  IL 32972
Product CodeLMA  
CFR Regulation Number892.2030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-15
Decision Date2013-10-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.