Cleared Traditional

K011311 - UROLOGIC

K011311 is an FDA 510(k) clearance for UROLOGIC, manufactured by Pck Electronic Industry and Trade Co, Ltd.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K011311 · Pck Electronic Industry and Trade Co, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
71d
Days
Class 2
Risk

K011311 is an FDA 510(k) clearance for the UROLOGIC. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Pck Electronic Industry and Trade Co, Ltd. (Ankara, TR). The FDA issued a Cleared decision on July 10, 2001 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

FDA 510(k) Submission Details - K011311

510(k) Number K011311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2001
Decision Date July 10, 2001
Days to Decision 71 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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