ARTIS ONE

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 Artis One.

Pre-market Notification Details

• Device ID: K133580
• 510k Number: K133580
• Device Name: ARTIS ONE
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Contact: Patricia D Jones
• Correspondent: Patricia D Jones; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-21
• Decision Date: 2014-04-28
• Summary: summary