FDA 510(k) Application Details - K242258

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K242258
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant ASG Superconductors S.P.A.
Corso Ferdinando Maria Perrone, 73/R
Genova 16152 IT
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Contact Leonardo Bertora
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 07/31/2024
Decision Date 11/26/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242258


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