YSIO

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.

Pre-market Notification Details

• Device ID: K081722
• 510k Number: K081722
• Device Name: YSIO
• Classification: System, X-ray, Stationary
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 Malvern, PA 19355
• Contact: Gary Johnson
• Correspondent: Gary Johnson; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MS E-50 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: 2008-06-18
• Decision Date: 2008-08-22
• Summary: summary