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: K042236
• 510k Number: K042236
• Device Name: G-SCAN
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: ESAOTE, S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250
• Contact: Carri Graham
• Correspondent: Carri Graham; ESAOTE, S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-18
• Decision Date: 2004-10-04
• Summary: summary