FDR Cross (DR-XD 3000)

Q: What is the product code of K212956?

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) K212956 · Fujifilm Corporation

Substantially Equivalent

510(k) numberK212956

Submission

Device name: FDR Cross (DR-XD 3000)
Applicant: Fujifilm Corporation
Ashigara Kami-Gun, JP
Received: September 16, 2021
Decision date: November 8, 2021
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
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
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K252229	Belliger AceOWB · Traditional	Genoray Co., Ltd.	04/02/2026SE

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Questions and answers

When was FDR Cross (DR-XD 3000) cleared by the FDA?

FDR Cross (DR-XD 3000) (K212956) received a 510(k) decision of Substantially Equivalent on November 8, 2021, 53 days after the submission was received.

What is the product code of K212956?

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