ARTIS Icono

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 Icono.

Pre-market Notification Details

• Device ID: K190768
• 510k Number: K190768
• Device Name: ARTIS Icono
• 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: IZI
• Subsequent Product Code: JAA
• Subsequent Product Code: JAK
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-26
• Decision Date: 2019-09-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869149325	K190768	000
04056869063317	K190768	000