Cleared Abbreviated

K151219 - Models 2200DR and 1600DR Digital Statio...

K151219 is an FDA 510(k) clearance for Models 2200DR and 1600DR Digital Statio..., manufactured by Beijing Polycon Medical Engineering Company. The device is a Class 2 Radiology device with product code KPR cleared through the Abbreviated 510(k) pathway after a 89-day FDA review.

K151219 · Beijing Polycon Medical Engineering Company · Radiology device
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Aug 2015
Decision
89d
Days
Class 2
Risk

K151219 is an FDA 510(k) clearance for the Models 2200DR and 1600DR Digital Stationary Radiographic Systems. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Beijing Polycon Medical Engineering Company (Beijing, CN). The FDA issued a Cleared decision on August 4, 2015 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Beijing Polycon Medical Engineering Company devices

FDA 510(k) Submission Details - K151219

510(k) Number K151219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2015
Decision Date August 04, 2015
Days to Decision 89 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

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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