K151219 - Models 2200DR and 1600DR Digital Stationary Radiographic Systems (FDA 510(k) Clearance)

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.

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