FDA.report

510(k) K131137

Device
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
Applicant
JVC KENWOOD CORPORATION
510(k) number
K131137
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2013-07-18
Date received
2013-04-23
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
TSUKASA TASHIRO
Address
300-Oya Ueda-Shi Nagano-Ken JP 386-0192 386-0192

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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