MobileRay Pulse SE Digital Imaging System

Q: What is the product code of K191503?

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) K191503 · Portavision Medical, LLC

Substantially Equivalent

510(k) numberK191503

Submission

Device name: MobileRay Pulse SE Digital Imaging System
Applicant: Portavision Medical, LLC
Jefferson, LA, US
Received: June 6, 2019
Decision date: September 4, 2019
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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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 MobileRay Pulse SE Digital Imaging System cleared by the FDA?

MobileRay Pulse SE Digital Imaging System (K191503) received a 510(k) decision of Substantially Equivalent on September 4, 2019, 90 days after the submission was received.

What is the product code of K191503?

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