FDR Visionary Suite

System, X-ray, Stationary

SHIMADZU CORPORATION

The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Fdr Visionary Suite.

Pre-market Notification Details

Device IDK152294
510k NumberK152294
Device Name:FDR Visionary Suite
ClassificationSystem, X-ray, Stationary
Applicant SHIMADZU CORPORATION 1 NISHINOKYO-KUWABARACHO NAKAGYO-KU Kyoto,  JP 604-8511
ContactToshio Kadowaki
CorrespondentToshio Kadowaki
SHIMADZU MEDICAL SYSTEMS 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto,  JP
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-13
Decision Date2016-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04540217057450 K152294 000
04540217064700 K152294 000
04540217064717 K152294 000
04540217064724 K152294 000
04540217052202 K152294 000
04540217052219 K152294 000
04540217052226 K152294 000
04540217057436 K152294 000
04540217057443 K152294 000
04540217064694 K152294 000

Trademark Results [FDR Visionary Suite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FDR VISIONARY SUITE
FDR VISIONARY SUITE
86312188 5191573 Live/Registered
FUJIFILM Medical Systems U.S.A., Inc.
2014-06-17

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