MAGNETOM Lumina

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 Lumina.

Pre-market Notification Details

• Device ID: K183244
• 510k Number: K183244
• Device Name: MAGNETOM Lumina
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-21
• Decision Date: 2019-01-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869230740	K183244	000