I5 Digital X-Ray Imaging System (with SDX-4336CP)

Q: What is the product code of K112180?

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) K112180 · Infimed, Inc.

Substantially Equivalent

510(k) numberK112180

Submission

Device name: I5 Digital X-Ray Imaging System (with SDX-4336CP)
Applicant: Infimed, Inc.
Liverpool, NY, US
Received: July 28, 2011
Decision date: August 10, 2011
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.

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K992794	Stingray DR, Model 1MQB · Traditional	11/09/1999SE
K992575	Cardiovascular Workstation, Model CWS 5000/CWS 3000LLZ · Traditional	10/07/1999SE
K962422	Infimed Dental SystemEHD · Traditional	09/11/1997SE
K963037	PatriotLLZ · Traditional	09/27/1996SE

Questions and answers

When was I5 Digital X-Ray Imaging System (with SDX-4336CP) cleared by the FDA?

I5 Digital X-Ray Imaging System (with SDX-4336CP) (K112180) received a 510(k) decision of Substantially Equivalent on August 10, 2011, 13 days after the submission was received.

What is the product code of K112180?

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