MAGNETOM Sola

System, Nuclear Magnetic Resonance Imaging

Siemens Medical Solutions USA, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Sola.

Pre-market Notification Details

• Device ID: K182129
• 510k Number: K182129
• Device Name: MAGNETOM Sola
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway 65-1A Malvern, PA 19355
• Contact: Cordell L. Fields
• Correspondent: Cordell L. Fields; Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway 65-1A Malvern, PA 19355
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-06
• Decision Date: 2018-10-12
• Summary: summary