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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K231133
Device Name neo315
Applicant
Neoscan Solution GmbH
Joseph-Von-Fraunhofer-Str. 6
Magdeburg,  DE 39106
Applicant Contact Roell Stefan
Correspondent
Neoscan Solution GmbH
Joseph-Von-Fraunhofer-Str. 6
Magdeburg,  DE 39106
Correspondent Contact Roell Stefan
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/21/2023
Decision Date 07/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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