ClarifEye R1.0, ClarifEye Needle

Q: What is the product code of K201743?

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) K201743 · Philips Medical Systems Nederlands B.V.

Substantially Equivalent

510(k) numberK201743

Submission

Device name: ClarifEye R1.0, ClarifEye Needle
Applicant: Philips Medical Systems Nederlands B.V.
Best, NL
Received: June 25, 2020
Decision date: February 23, 2021
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 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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K253670	SmartCT (R3.0 (L10))OWB · Abbreviated	Philips Medical Systems B.V.	07/10/2026SE
K252735	C-beamOWB · Traditional	Pulmera, Inc.	05/22/2026SE
K252503	Intelligent NROWB · Traditional	Canon, Inc.	04/30/2026SE
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

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K181311	Philips Hemodynamic Application R1.0MWI · Abbreviated	09/07/2018SE
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K162025	IntelliSpace Portal PlatformLLZ · Traditional	10/18/2016SE
K153324	Ingenia 1.5T and Ingenia 1.5T S R5.2LNH · Abbreviated	03/22/2016SE
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Questions and answers

When was ClarifEye R1.0, ClarifEye Needle cleared by the FDA?

ClarifEye R1.0, ClarifEye Needle (K201743) received a 510(k) decision of Substantially Equivalent on February 23, 2021, 243 days after the submission was received.

What is the product code of K201743?

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