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: K132951
• 510k Number: K132951
• Device Name: MAGNETOM AERA
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355
• Contact: Nadia Sookdeo
• Correspondent: Nadia Sookdeo; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-19
• Decision Date: 2013-11-15
• Summary: summary