MAGNETOM Amira

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 Amira.

Pre-market Notification Details

• Device ID: K173600
• 510k Number: K173600
• Device Name: MAGNETOM Amira
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355
• Contact: Martin Rajchel
• Correspondent: Martin Rajchel; Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 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: 2017-11-21
• Decision Date: 2017-12-19
• Summary: summary