SOMATOM Go Platform – SOMATOM Go.Now, Go.Up, Go.All, Go.Top, Go.Sim, Go.Open Pro, Scan & GO

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 Go Platform – Somatom Go.now, Go.up, Go.all, Go.top, Go.sim, Go.open Pro, Scan & Go.

Pre-market Notification Details

• Device ID: K192061
• 510k Number: K192061
• Device Name: SOMATOM Go Platform – SOMATOM Go.Now, Go.Up, Go.All, Go.Top, Go.Sim, Go.Open Pro, Scan & GO
• Classification: System, X-ray, Tomography, Computed
• Applicant: Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932
• Contact: Alaine Medio
• Correspondent: Alaine Medio; Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-01
• Decision Date: 2019-11-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869249230	K192061	000
04056869249247	K192061	000
04056869239743	K192061	000
04056869239736	K192061	000