Cleared Traditional

K103425 - ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM

K103425 is an FDA 510(k) clearance for ZEN-7000, manufactured by Genoray America, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K103425 · Genoray America, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
127d
Days
Class 2
Risk

K103425 is an FDA 510(k) clearance for the ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Genoray America, Inc. (Orange, US). The FDA issued a Cleared decision on March 29, 2011 after a review of 127 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.

FDA 510(k) Submission Details - K103425

510(k) Number K103425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date March 29, 2011
Days to Decision 127 days
Submission Type Traditional
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
20d slower than avg
Panel avg: 107d · This submission: 127d
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 324
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K103425.
OEC(R) 9800, OEC(R) 9800 PLUS
K111551 · Ge Oec Medical Systems, Inc. · Oct 2011
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
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
K103416 · Infimed, 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
K103425 · ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
Download PDF FDA Summary Genoray America, Inc.