FDA 510(k) Application Details - K241925

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K241925
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant Perspectum Ltd
Gemini One,
5520, John Smith Drive
Oxford OX4 2LL GB
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Contact Bhaskar Chikkanna
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 07/01/2024
Decision Date 10/02/2024
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 K241925


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