MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma Fit

System, Nuclear Magnetic Resonance Imaging

SIEMENS MEDICAL SOLUTIONS, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Magnetom Aera, Magnetom Skyra, Magnetom Prisma, Magnetom Prisma Fit.

Pre-market Notification Details

• Device ID: K153343
• 510k Number: K153343
• Device Name: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma Fit
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: SIEMENS MEDICAL SOLUTIONS, INC. 40 LIBERTY BOULEVARD MAIL CODE 65-1A Malvern, PA 19355
• Contact: John Urtz
• Correspondent: John Urtz; SIEMENS MEDICAL SOLUTIONS, INC. 40 LIBERTY BOULEVARD MAIL CODE 65-1A Malvern, PA 19355
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-19
• Decision Date: 2016-04-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869022840	K153343	000
04056869006734	K153343	000
04056869015514	K153343	000
04056869015521	K153343	000
04056869022628	K153343	000
04056869022635	K153343	000
04056869022659	K153343	000
04056869022680	K153343	000
04056869022833	K153343	000
04056869006727	K153343	000