ADMIRE

System, X-ray, Tomography, Computed

SIEMENS MEDICAL SOLUTIONS, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Admire.

Pre-market Notification Details

• Device ID: K153360
• 510k Number: K153360
• Device Name: ADMIRE
• Classification: System, X-ray, Tomography, Computed
• Applicant: SIEMENS MEDICAL SOLUTIONS, INC. 40 LIBERTY BOULEVARD MAIL CODE 65-1A Malvern, PA 19355
• Contact: John Urtz
• Correspondent: John Urtz; SIEMENS MEDICAL SOLUTIONS, INC. 40 LIBERTY BOULEVARD 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: 2015-11-20
• Decision Date: 2016-06-29
• Summary: summary