G-scan Brio, S-scan

System, Nuclear Magnetic Resonance Imaging

Esaote S.p.A.

The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for G-scan Brio, S-scan.

Pre-market Notification Details

Device IDK161973
510k NumberK161973
Device Name:G-scan Brio, S-scan
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Esaote S.p.A. Via Siffredi 58 Genova,  IT 16153
ContactMaria Marzapane
CorrespondentAllison Scott
Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 Indianapolis,  IN  46268
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-18
Decision Date2016-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304452719 K161973 000

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