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: K152283
• 510k Number: K152283
• Device Name: MAGNETOM Amira
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Contact: Cordell L Fields
• Correspondent: Cordell L Fields; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Product Code: LNH
• Subsequent Product Code: LNI
• Subsequent Product Code: MOS
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-12
• Decision Date: 2015-12-24
• Summary: summary