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