Somatom Confidence ® RT Pro

System, X-ray, Tomography, Computed

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 Somatom Confidence ® Rt Pro.

Pre-market Notification Details

• Device ID: K162302
• 510k Number: K162302
• Device Name: Somatom Confidence ® RT Pro
• Classification: System, X-ray, Tomography, Computed
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD., MAIL CODE 65-1A Malvern, PA 19355
• Contact: Kimberly Mangum
• Correspondent: Kimberly Mangum; SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD., MAIL CODE 65-1A Malvern, PA 19355
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-17
• Decision Date: 2016-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869011011	K162302	000