MODULEAF

Block, Beam-shaping, Radiation Therapy

MRC SYSTEMS GMBH

The following data is part of a premarket notification filed by Mrc Systems Gmbh with the FDA for Moduleaf.

Pre-market Notification Details

Device IDK030609
510k NumberK030609
Device Name:MODULEAF
ClassificationBlock, Beam-shaping, Radiation Therapy
Applicant MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg,  DE D-69123
ContactJoerg Stein
CorrespondentJoerg Stein
MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg,  DE D-69123
Product CodeIXI  
CFR Regulation Number892.5710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-26
Decision Date2003-03-17
Summary:summary

Trademark Results [MODULEAF]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MODULEAF
MODULEAF
78097851 2688756 Live/Registered
SIEMENS MEDICAL SOLUTIONS USA, INC.
2001-12-12

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