MAGNETOM Aera

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 Aera.

Pre-market Notification Details

• Device ID: K190138
• 510k Number: K190138
• Device Name: MAGNETOM Aera
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-1A Malvern, PA 19355
• Contact: Cordell L. Fields
• Correspondent: Cordell L. Fields; Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-1A Malvern, PA 19355
• Product Code: LNH
• Subsequent Product Code: LNI
• Subsequent Product Code: MOS
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-29
• Decision Date: 2019-02-15
• Summary: summary