SAFIRE

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 Safire.

Pre-market Notification Details

• Device ID: K103424
• 510k Number: K103424
• Device Name: SAFIRE
• Classification: System, X-ray, Tomography, Computed
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355
• Contact: Alicia Bustos-juergensen
• Correspondent: Alicia Bustos-juergensen; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 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: 2010-11-22
• Decision Date: 2011-11-22
• Summary: summary