Multitom Rax

Interventional Fluoroscopic X-ray System

Siemens Medical Solutions

The following data is part of a premarket notification filed by Siemens Medical Solutions with the FDA for Multitom Rax.

Pre-market Notification Details

• Device ID: K221281
• 510k Number: K221281
• Device Name: Multitom Rax
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: Siemens Medical Solutions 40 Liberty Boulevard Malvern, PA 19355
• Contact: Denise Adams
• Correspondent: Denise Adams; Siemens Medical Solutions 40 Liberty Boulevard Malvern, PA 19355
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: JAK
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-05-03
• Decision Date: 2022-11-17