S-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 S-scan.

Pre-market Notification Details

• Device ID: K151668
• 510k Number: K151668
• Device Name: S-scan
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: ESAOTE S.P.A. VIA STIFFREDI 58 Genova, IT 16153
• Contact: Donatella Ragghianti
• Correspondent: Kelli Anderson; NAVIGANT CONSULTING, INC. 9001 WESLEYAN ROAD, SUITE 200 Indianapolis, IN 46268
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-19
• Decision Date: 2015-09-08
• Summary: summary