FDA 510(k), K183685, System, Nuclear Magnetic Resonance Imaging

Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Device Name: O-Scan
Applicant: Esaote S.p.A, Via Enrico Melen 77, Genova,  IT 16152
Applicant Contact: Massimo Polignano
Regulation Number: 892.1000
Classification Product Code: LNH  
Date Received:    12/28/2018
Decision Date:    01/22/2019
Decision:    Substantially Equivalent (SESE)
Regulation Medical Specialty:    Radiology

Number of pages: 633 (originally 2081, fully redacted pages removed)