21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)

System, Image Processing, Radiological

TOKOTU ELECTRIC CO., LTD.

The following data is part of a premarket notification filed by Tokotu Electric Co., Ltd. with the FDA for 21.3 Inch (53cm) Monochrome Digital Mammography Lcd Monitor Ms51i2, (mdl2123a).

Pre-market Notification Details

Device IDK081242
510k NumberK081242
Device Name:21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
ClassificationSystem, Image Processing, Radiological
Applicant TOKOTU ELECTRIC CO., LTD. 300 OYA, UEDA Nagano,  JP 386-0192
ContactMikio Hasegawa
CorrespondentMikio Hasegawa
TOKOTU 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 Received2008-05-01
Decision Date2008-06-11
Summary:summary

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