Cleared Traditional

K102529 - D2RF DIGITAL DYNAMIC REMOTE SYSTEM

K102529 is an FDA 510(k) clearance for D2RF DIGITAL DYNAMIC REMOTE SYSTEM, manufactured by Stephanix Radiological Systems. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K102529 · Stephanix Radiological Systems · Radiology device
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Oct 2010
Decision
35d
Days
Class 2
Risk

K102529 is an FDA 510(k) clearance for the D2RF DIGITAL DYNAMIC REMOTE SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Stephanix Radiological Systems (Naples, US). The FDA issued a Cleared decision on October 7, 2010 after a review of 35 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 Stephanix Radiological Systems devices

FDA 510(k) Submission Details - K102529

510(k) Number K102529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2010
Decision Date October 07, 2010
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
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 256
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