Cleared Traditional

K032761 - KMC-950 C-ARM MOBILE SYSTEM

K032761 is an FDA 510(k) clearance for KMC-950 C-ARM MOBILE SYSTEM, manufactured by United Radiology Systems, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K032761 · United Radiology Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
252d
Days
Class 2
Risk

K032761 is an FDA 510(k) clearance for the KMC-950 C-ARM MOBILE SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by United Radiology Systems, Inc. (Deerfield, US). The FDA issued a Cleared decision on May 14, 2004 after a review of 252 days - an extended review 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: 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 United Radiology Systems, Inc. devices

FDA 510(k) Submission Details - K032761

510(k) Number K032761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2003
Decision Date May 14, 2004
Days to Decision 252 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
145d slower than avg
Panel avg: 107d · This submission: 252d
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 277
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K032761.
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
K042793 · Siemens Medi Cal Solutions, Inc. · Oct 2004
INNOVA 4100, INNOVA 3100
K042053 · Ge Medical Systems, Inc. · Aug 2004
AXIOM ARTIS U
K040675 · Siemens Medical Systems, Inc. · Jun 2004
ALLURA XPER FD20
K033737 · Philips Medical Systems North America, Inc. · Dec 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · Ge Medical Systems, Inc. · Oct 2003
INNOVA 3100
K031637 · GE Medical Systems · Aug 2003