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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K211658
Device Name OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
Applicant
NORAS MRI products GmbH
Leibnizstr. 4
Hoechberg,  DE 97204
Applicant Contact Manuel Noras
Correspondent
NORAS MRI products GmbH
Leibnizstr. 4
Hoechberg,  DE 97204
Correspondent Contact Patricia Kirchner
Regulation Number892.1000
Classification Product Code
MOS  
Subsequent Product Code
HBL  
Date Received05/28/2021
Decision Date 03/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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