Cleared Traditional

K152813 - FS-500DDR Medical Radiographic X-Ray System

K152813 is an FDA 510(k) clearance for FS-500DDR Medical 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 431-day FDA review.

K152813 · Orich Medical Equipment (Tianjin Co., Ltd. · Radiology device
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Dec 2016
Decision
431d
Days
Class 2
Risk

K152813 is an FDA 510(k) clearance for the FS-500DDR Medical 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. (Tianjin Economic Technological Developme, CN). The FDA issued a Cleared decision on December 2, 2016 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Orich Medical Equipment (Tianjin Co., Ltd. devices

FDA 510(k) Submission Details - K152813

510(k) Number K152813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date December 02, 2016
Days to Decision 431 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
324d slower than avg
Panel avg: 107d · This submission: 431d
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.

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