ControlRad Select Model Z

Q: What is the product code of K213455?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.

FDA 510(k) K213455 · Controlrad, Inc.

Substantially Equivalent

510(k) numberK213455

Submission

Device name: ControlRad Select Model Z
Applicant: Controlrad, Inc.
Norcross, GA, US
Received: October 26, 2021
Decision date: November 24, 2021
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OWB – Interventional Fluoroscopic X-Ray System
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

Interventional fluoroscopy

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More from Genoray Co., Ltd.

510(k)	Device	Decision
K211782	ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9OWB · Special	07/01/2021SE
K202431	ControlRad Select Model ZOWB · Traditional	12/23/2020SE
K200663	ControlRad Trace Model 9OWB · Traditional	06/24/2020SE
K200238	ControlRad Sterile CoverKKX · Traditional	04/26/2020SE
K183109	ControlRad Trace Model 8OWB · Traditional	05/13/2019SE

Questions and answers

When was ControlRad Select Model Z cleared by the FDA?

ControlRad Select Model Z (K213455) received a 510(k) decision of Substantially Equivalent on November 24, 2021, 29 days after the submission was received.

What is the product code of K213455?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.