Virtual C DRF-NEO Digital Imaging System

Q: What is the product code of K212557?

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) K212557 · Portavision Medical, LLC

Substantially Equivalent

510(k) numberK212557

Submission

Device name: Virtual C DRF-NEO Digital Imaging System
Applicant: Portavision Medical, LLC
Jefferson, LA, US
Received: August 13, 2021
Decision date: September 24, 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
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.

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K211191	Virtual C DRF Digital Imaging SystemOWB · Traditional	06/24/2021SE
K191503	MobileRay Pulse SE Digital Imaging SystemOWB · Traditional	09/04/2019SE
K133524	Pvmed DDR 2430TMQB · Traditional	04/16/2014SE
K083048	Neoray DR 2520 Digital Imaging SystemIZL · Traditional	11/21/2008SE
K072766	Pvmed DDR 2520 Digital Imaging SystemIXK · Traditional	12/11/2007SE

Questions and answers

When was Virtual C DRF-NEO Digital Imaging System cleared by the FDA?

Virtual C DRF-NEO Digital Imaging System (K212557) received a 510(k) decision of Substantially Equivalent on September 24, 2021, 42 days after the submission was received.

What is the product code of K212557?

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