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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 K253413
Device Name LiverMultiScan (v6.0)
Applicant
Perspectum, Ltd.
Gemini One, 5520 John Smith Dr.
Oxford,  GB OX42LL
Applicant Contact Bhaskar Chikkanna
Correspondent
Perspectum, Ltd.
Gemini One, 5520 John Smith Dr.
Oxford,  GB OX42LL
Correspondent Contact Bhaskar Chikkanna
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/01/2025
Decision Date 03/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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