SYMBIA

System, Tomography, Computed, Emission

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 Symbia.

Pre-market Notification Details

• Device ID: K131634
• 510k Number: K131634
• Device Name: SYMBIA
• Classification: System, Tomography, Computed, Emission
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 -2751
• Contact: Elaine Chang
• Correspondent: Elaine Chang; SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 -2751
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-06-04
• Decision Date: 2013-08-16
• Summary: summary