Cleared Traditional

K063121 - PORTABLE X-RAY SYSTEM, MODEL PORT-X II

K063121 is an FDA 510(k) clearance for PORTABLE X-RAY SYSTEM, manufactured by Genoray Co., Ltd.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K063121 · Genoray Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
91d
Days
Class 2
Risk

K063121 is an FDA 510(k) clearance for the PORTABLE X-RAY SYSTEM, MODEL PORT-X II. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Genoray Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on January 11, 2007 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Genoray Co., Ltd. devices

FDA 510(k) Submission Details - K063121

510(k) Number K063121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2006
Decision Date January 11, 2007
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 Consultant

Underwriters Laboratories, Inc.
MARC M MOUSER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 156
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