MULTIX Impact

System, X-ray, Stationary

Siemens Medical Solutions, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Multix Impact.

Pre-market Notification Details

• Device ID: K182517
• 510k Number: K182517
• Device Name: MULTIX Impact
• Classification: System, X-ray, Stationary
• Applicant: Siemens Medical Solutions, Inc. 40 Liberty Boulevard, Mail Stop 65-1A Malvern, PA 19355
• Contact: Denise Adams
• Correspondent: Denise Adams; Siemens Medical Solutions, Inc. 40 Liberty Boulevard, Mail Stop 65-1A Malvern, PA 19355
• Product Code: KPR
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-13
• Decision Date: 2019-01-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869226545	K182517	000