ControlRad Trace Model 9

Q: What is the product code of K200663?

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) K200663 · Controlrad, Inc.

Substantially Equivalent

510(k) numberK200663

Submission

Device name: ControlRad Trace Model 9
Applicant: Controlrad, Inc.
Norcross, GA, US
Received: March 13, 2020
Decision date: June 24, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 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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K252735	C-beamOWB · Traditional	Pulmera, Inc.	05/22/2026SE
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K254173	ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/24/2026SE
K253752	ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/23/2026SE
K252229	Belliger AceOWB · Traditional	Genoray Co., Ltd.	04/02/2026SE

More from Genoray Co., Ltd.

510(k)	Device	Decision
K213455	ControlRad Select Model ZOWB · Special	11/24/2021SE
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
K200238	ControlRad Sterile CoverKKX · Traditional	04/26/2020SE
K183109	ControlRad Trace Model 8OWB · Traditional	05/13/2019SE

Questions and answers

When was ControlRad Trace Model 9 cleared by the FDA?

ControlRad Trace Model 9 (K200663) received a 510(k) decision of Substantially Equivalent on June 24, 2020, 103 days after the submission was received.

What is the product code of K200663?

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