Cleared Abbreviated

K151219 - Models 2200DR and 1600DR Digital Stationary Radiographic Systems

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Kamm & Associates
DANIEL KAMM

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 320
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