Cleared Traditional

K092772 - PORTABLE X-RAY SYSTEM, MODEL HAND-RAY

K092772 is an FDA 510(k) clearance for PORTABLE X-RAY SYSTEM, manufactured by Hanjin Digi-X Co., Ltd.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K092772 · Hanjin Digi-X Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
119d
Days
Class 2
Risk

K092772 is an FDA 510(k) clearance for the PORTABLE X-RAY SYSTEM, MODEL HAND-RAY. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Hanjin Digi-X Co., Ltd. (Salt Lake City, US). The FDA issued a Cleared decision on January 6, 2010 after a review of 119 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.

FDA 510(k) Submission Details - K092772

510(k) Number K092772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2009
Decision Date January 06, 2010
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 187
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K092772.
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ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
K090749 · Villa Sistemi Medicali S.P.A. · May 2009
K092772 · PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
Download PDF FDA Summary Hanjin Digi-X Co., Lt…