MAGNETOM ESSENZA

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 Essenza.

Pre-market Notification Details

• Device ID: K161795
• 510k Number: K161795
• Device Name: MAGNETOM ESSENZA
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Malvern, PA 19355
• Contact: Cordell L. Fields
• Correspondent: Cordell L. Fields; Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway 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: 2016-06-30
• Decision Date: 2016-11-18
• Summary: summary