Cleared Traditional

K142617 - ArcCHECK

K142617 is an FDA 510(k) clearance for ArcCHECK, manufactured by Sun Nuclear Corporation. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K142617 · Sun Nuclear Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
430d
Days
Class 2
Risk

K142617 is an FDA 510(k) clearance for the ArcCHECK. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Sun Nuclear Corporation (Melbourne, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

FDA 510(k) Submission Details - K142617

510(k) Number K142617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2014
Decision Date November 20, 2015
Days to Decision 430 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
323d slower than avg
Panel avg: 107d · This submission: 430d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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

James Luker
James Luker

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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