G-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.

Pre-market Notification Details

• Device ID: K110238
• 510k Number: K110238
• Device Name: G-SCAN
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: ESAOTE S.P.A. 11460 N MERIDIAN STREET SUITE 150 Carmel, IN 46032
• Contact: Allison Scott
• Correspondent: Allison Scott; ESAOTE S.P.A. 11460 N MERIDIAN STREET SUITE 150 Carmel, IN 46032
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2011-01-26
• Decision Date: 2011-02-17
• Summary: summary