YSIO X.pree

System, X-ray, Stationary

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 Ysio X.pree.

Pre-market Notification Details

• Device ID: K201670
• 510k Number: K201670
• Device Name: YSIO X.pree
• Classification: System, X-ray, Stationary
• Applicant: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
• Contact: Andrew Turner
• Correspondent: Andrew Turner; Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
• Product Code: KPR
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-19
• Decision Date: 2020-10-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869232904	K201670	000