Cleared Traditional

K160857 - HF 718BD X-Ray System

K160857 is an FDA 510(k) clearance for HF 718BD X-Ray System, manufactured by Arquilla, Inc. Dba X-Cel X-Ray Corporation. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K160857 · Arquilla, Inc. Dba X-Cel X-Ray Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
332d
Days
Class 2
Risk

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.

FDA 510(k) Submission Details - K160857

510(k) Number K160857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2016
Decision Date February 24, 2017
Days to Decision 332 days
Submission Type Traditional
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
225d slower than avg
Panel avg: 107d · This submission: 332d
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.

Regulatory Consultant

Cjp Consulting, Inc.
Cynthia J. Pillar

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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K160857 · HF 718BD X-Ray System
Download PDF FDA Summary Arquilla, Inc. Dba X-…