LiverMultiScan

System, Nuclear Magnetic Resonance Imaging

Perspectum LTD

The following data is part of a premarket notification filed by Perspectum Ltd with the FDA for Livermultiscan.

Pre-market Notification Details

Device IDK202170
510k NumberK202170
Device Name:LiverMultiScan
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Perspectum LTD Gemini One, 5520 John Smith Drive Oxford,  GB Ox4 2ll
ContactJaco Jacobs
CorrespondentJaco Jacobs
Perspectum LTD Gemini One, 5520 John Smith Drive Oxford,  GB Ox4 2ll
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2020-10-02

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