Cleared Traditional

K030544 - RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM

K030544 is an FDA 510(k) clearance for RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM, manufactured by Sigma Vision, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030544 · Sigma Vision, Inc. · Radiology device
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May 2003
Decision
90d
Days
Class 2
Risk

K030544 is an FDA 510(k) clearance for the RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Sigma Vision, Inc. (Rockville, US). The FDA issued a Cleared decision on May 21, 2003 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Vision, Inc. devices

FDA 510(k) Submission Details - K030544

510(k) Number K030544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date May 21, 2003
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 282
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K030544.
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