Cleared Special

K103416 - NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM

K103416 is an FDA 510(k) clearance for NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM, manufactured by Infimed, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Special 510(k) pathway after a 115-day FDA review.

K103416 · Infimed, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
115d
Days
Class 2
Risk

K103416 is an FDA 510(k) clearance for the NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Infimed, Inc. (Great Neck, US). The FDA issued a Cleared decision on March 17, 2011 after a review of 115 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103416

510(k) Number K103416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date March 17, 2011
Days to Decision 115 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

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 324
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K103416.
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
K112180 · Infimed, Inc. · Aug 2011
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
K111344 · Infimed, Inc. · Jun 2011
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
K103425 · Genoray America, Inc. · Mar 2011
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
K102529 · Stephanix Radiological Systems · Oct 2010
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
K101868 · Toshiba America Medical Systems, In.C · Sep 2010
CS-SERIES-FP
K100102 · Omega Medical Imaging, Inc. · Aug 2010
K103416 · NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
Download PDF FDA Summary Infimed, Inc.