Cleared Traditional

K212212 - Multitom Rax with True2scale Body Scan ...

K212212 is an FDA 510(k) clearance for Multitom Rax with True2scale Body Scan ..., manufactured by Siemens Medical Solutions. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K212212 · Siemens Medical Solutions · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
218d
Days
Class 2
Risk

K212212 is an FDA 510(k) clearance for the Multitom Rax with True2scale Body Scan Option. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on February 18, 2022 after a review of 218 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions devices

FDA 510(k) Submission Details - K212212

510(k) Number K212212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2021
Decision Date February 18, 2022
Days to Decision 218 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 107d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 245
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K212212.
Shield System
K212159 · Radiaction , Ltd. · Mar 2022
SURGIVISIO Device
K220627 · Ecential Robotics · Mar 2022
ZEN-2090 Turbo
K211780 · Genoray Co., Ltd. · Mar 2022
D²RS and D²RS 9090
K213479 · Stephanix · Dec 2021
Cydar EV (Series B) and Cydar EV Maps
K212442 · Cydar , Ltd. · Dec 2021
ControlRad Select Model Z
K213455 · Controlrad, Inc. · Nov 2021