Cleared Traditional

ControlRad Select Model Z

K202431 · Controlrad, Inc. · Radiology

Dec 2020

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K202431 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 December 23, 2020, 120 days after receiving the submission on August 25, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K202431 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2020
Decision Date	December 23, 2020
Days to Decision	120 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