SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL

System, Image Processing, Radiological

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 Syno Mr Neurology, Syngo Mr Oncology, Syngo. Mr Brevis, Syngo Mmr General.

Pre-market Notification Details

• Device ID: K133401
• 510k Number: K133401
• Device Name: SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
• Classification: System, Image Processing, Radiological
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Contact: Nadia Sookdeo
• Correspondent: Nadia Sookdeo; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-06
• Decision Date: 2014-03-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869043227	K133401	000
04056869043210	K133401	000
04056869043180	K133401	000
04056869043173	K133401	000
04056869012872	K133401	000
04056869012865	K133401	000
04056869012797	K133401	000
04056869012780	K133401	000