RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

System, X-ray, Mobile

SEDECAL SA

The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Radpro® Mobile 40kw; Radpro® Mobile 40kw Flexplus, Model Sm-40hf-b-d-vir.

Pre-market Notification Details

Device IDK161345
510k NumberK161345
Device Name:RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
ClassificationSystem, X-ray, Mobile
Applicant SEDECAL SA PELAYA, 9 POL.; POL. IND. "RIO DE JANEIRO" Algete,  ES 28110
ContactMa Luisa Gomez De Aguero
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-13
Decision Date2016-07-06
Summary:summary

Trademark Results [RadPRO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RADPRO
RADPRO
86677831 4901253 Live/Registered
Virtual Imaging, Inc.
2015-06-29
RADPRO
RADPRO
86239190 not registered Dead/Abandoned
Nutrition Resource, Inc
2014-04-01
RADPRO
RADPRO
79126591 not registered Dead/Abandoned
Kromek Limited
2012-09-11
RADPRO
RADPRO
77505558 3756555 Dead/Cancelled
RADPRO LLC
2008-06-23
RADPRO
RADPRO
76642334 3197896 Live/Registered
Virtual Imaging, Inc.
2005-07-06
RADPRO
RADPRO
74721434 1995477 Live/Registered
Landauer, Inc.
1995-08-28

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