Cios Select

Interventional Fluoroscopic X-ray System

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 Cios Select.

Pre-market Notification Details

• Device ID: K153232
• 510k Number: K153232
• Device Name: Cios Select
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD 65-1A Malvern, PA 19355
• Contact: Patricia D Jones
• Correspondent: Patricia D Jones; SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD 65-1A Malvern, PA 19355
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-09
• Decision Date: 2016-02-10
• Summary: summary