Cleared Special

ControlRad Select Model Z

K213455 · Controlrad, Inc. · Radiology

Nov 2021

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K213455 is an FDA 510(k) clearance for the ControlRad Select Model Z, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Controlrad, Inc. (Norcross, US). The FDA issued a Cleared decision on November 24, 2021, 29 days after receiving the submission on October 26, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K213455 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 2021
Decision Date	November 24, 2021
Days to Decision	29 days
Submission Type	Special
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