Cios Spin

Interventional Fluoroscopic X-ray System

Siemens Medical Systems USA, Inc.

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

Pre-market Notification Details

• Device ID: K210054
• 510k Number: K210054
• Device Name: Cios Spin
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
• Contact: Cordell Fields
• Correspondent: Cordell Fields; Siemens Healthcare GmbH Roentgenstrasse 19-21 Kemnath, DE 95478
• 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: 2021-01-08
• Decision Date: 2021-02-05