SOMATOM SPIRIT

System, X-ray, Tomography, Computed

SIEMENS MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

• Device ID: K042328
• 510k Number: K042328
• Device Name: SOMATOM SPIRIT
• Classification: System, X-ray, Tomography, Computed
• Applicant: SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406
• Contact: Nealie Hartman
• Correspondent: Nealie Hartman; SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-27
• Decision Date: 2004-09-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869010281	K042328	000
04056869010274	K042328	000