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: K162339
• 510k Number: K162339
• Device Name: Scenium
• Classification: System, Image Processing, Radiological
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC 810 INNOVATION DRIVE Knoxville, TN 37932
• Contact: Veronica Padharia
• Correspondent: Veronica Padharia; SIEMENS MEDICAL SOLUTIONS USA, INC 810 INNOVATION DRIVE Knoxville, TN 37932
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-22
• Decision Date: 2016-09-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869041087	K162339	000