Cleared Traditional

K120034 - RADIOGRAPHIC X-RAY SYSTEM

K120034 is an FDA 510(k) clearance for RADIOGRAPHIC X-RAY SYSTEM, manufactured by Orich Medical Equipment (Tianjin Co., Ltd.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K120034 · Orich Medical Equipment (Tianjin Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2012
Decision
104d
Days
Class 2
Risk

K120034 is an FDA 510(k) clearance for the RADIOGRAPHIC X-RAY SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Orich Medical Equipment (Tianjin Co., Ltd. (Miami, US). The FDA issued a Cleared decision on April 17, 2012 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Orich Medical Equipment (Tianjin Co., Ltd. devices

FDA 510(k) Submission Details - K120034

510(k) Number K120034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2012
Decision Date April 17, 2012
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 206
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