SOMATOM SCOPE/SOMATOM SCOPE POWER

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 Scope/somatom Scope Power.

Pre-market Notification Details

• Device ID: K140912
• 510k Number: K140912
• Device Name: SOMATOM SCOPE/SOMATOM SCOPE POWER
• Classification: System, X-ray, Tomography, Computed
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Contact: Eve Davis
• Correspondent: Eve Davis; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. 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: 2014-04-09
• Decision Date: 2014-09-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869013060	K140912	000
04056869013053	K140912	000
04056869010328	K140912	000
04056869010311	K140912	000