SCENIUM

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 Scenium.

Pre-market Notification Details

• Device ID: K133654
• 510k Number: K133654
• Device Name: SCENIUM
• Classification: System, Image Processing, Radiological
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60192
• Contact: Maria Ebio
• Correspondent: Maria Ebio; SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60192
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-27
• Decision Date: 2014-02-28
• Summary: summary