K160857 - HF 718BD X-Ray System (FDA 510(k) Clearance)

K160857 is an FDA 510(k) clearance for the HF 718BD X-Ray System. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Arquilla, Inc. Dba X-Cel X-Ray Corporation (Crystal Lake, US). The FDA issued a Cleared decision on February 24, 2017 after a review of 332 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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