Cleared Special

K053279 - UROVANTAGE

K053279 is an FDA 510(k) clearance for UROVANTAGE, manufactured by Pck Electronic Industry & Trade Co., Ltd.. The device is a Class 2 Radiology device with product code OWB cleared through the Special 510(k) pathway after a 29-day FDA review.

K053279 · Pck Electronic Industry & Trade Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
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Dec 2005
Decision
29d
Days
Class 2
Risk

K053279 is an FDA 510(k) clearance for the UROVANTAGE. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Pck Electronic Industry & Trade Co., Ltd. (Washington, US). The FDA issued a Cleared decision on December 22, 2005 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pck Electronic Industry & Trade Co., Ltd. devices

FDA 510(k) Submission Details - K053279

510(k) Number K053279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2005
Decision Date December 22, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 242
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K053279.
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AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
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MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
K052884 · Toshiba America Medical Systems, In.C · Oct 2005
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · Ge Healthcare · Sep 2005
INNOVA 2100
K050489 · Ge Medical Systems, LLC · Mar 2005