Cios Connect

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 Connect.

Pre-market Notification Details

• Device ID: K153147
• 510k Number: K153147
• Device Name: Cios Connect
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
• Contact: Patricia D. Jones
• Correspondent: Patricia D. Jones; Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-30
• Decision Date: 2016-01-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869009049	K153147	000