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: K111803
• 510k Number: K111803
• Device Name: G-SCAN
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: ESAOTE, S.P.A. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268
• Contact: Allison Scott
• Correspondent: Allison Scott; ESAOTE, S.P.A. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2011-06-27
• Decision Date: 2011-07-15
• Summary: summary