21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR

System, Image Processing, Radiological

TOTOKU ELECTRIC CO., LTD

The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 21.3 Inch (54cm) Monochrome Digital Mammography Lcd Monitor.

Pre-market Notification Details

Device IDK111496
510k NumberK111496
Device Name:21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
ClassificationSystem, Image Processing, Radiological
Applicant TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano,  JP 386-0192
ContactTsukasa Tashiro
CorrespondentTsukasa Tashiro
TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano,  JP 386-0192
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-31
Decision Date2011-09-26
Summary:summary

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