Cleared Traditional

K102529 - D2RF DIGITAL DYNAMIC REMOTE SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102529 · Stephanix Radiological Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 318
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K102529.
Intelligent NR
K252503 · Canon, Inc. · Apr 2026
ARTIS icono floor
K254173 · Siemens Medical Solutions USA, Inc. · Apr 2026
ARTIS genio floor
K253752 · Siemens Medical Solutions USA, Inc. · Apr 2026
BELLIGER ACE
K252229 · Genoray Co., Ltd. · Apr 2026
Trinias
K252099 · Shimadzu Corporation · Mar 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
K253584 · Canon Medical Systems Corporation · Mar 2026