Cleared Traditional

K140041 - ZEN-7000

K140041 is an FDA 510(k) clearance for ZEN-7000, manufactured by Genoray Co., Ltd.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K140041 · Genoray Co., Ltd. · Radiology device
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Nov 2014
Decision
324d
Days
Class 2
Risk

K140041 is an FDA 510(k) clearance for the ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Genoray Co., Ltd. (Tustin, US). The FDA issued a Cleared decision on November 28, 2014 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Genoray Co., Ltd. devices

FDA 510(k) Submission Details - K140041

510(k) Number K140041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2014
Decision Date November 28, 2014
Days to Decision 324 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
217d slower than avg
Panel avg: 107d · This submission: 324d
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.

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All 245
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