Cleared Traditional

Multitom Rax

K221281 · Siemens Medical Solutions · Radiology

Nov 2022

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K221281 is an FDA 510(k) clearance for the Multitom Rax, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on November 17, 2022, 198 days after receiving the submission on May 3, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K221281 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2022
Decision Date	November 17, 2022
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy