CIOS ALPHA

Interventional Fluoroscopic X-ray System

SIEMENS MEDICAL SOLUTIONS, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Cios Alpha.

Pre-market Notification Details

• Device ID: K132094
• 510k Number: K132094
• Device Name: CIOS ALPHA
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355
• Contact: Darren Dorman
• Correspondent: Darren Dorman; SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-08
• Decision Date: 2014-03-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869009032	K132094	000