Cleared Traditional

K183109 - ControlRad Trace Model 8

K183109 is an FDA 510(k) clearance for ControlRad Trace Model 8, manufactured by Controlrad, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K183109 · Controlrad, Inc. · Radiology device
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May 2019
Decision
186d
Days
Class 2
Risk

K183109 is an FDA 510(k) clearance for the ControlRad Trace Model 8. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Controlrad, Inc. (Radnor, US). The FDA issued a Cleared decision on May 13, 2019 after a review of 186 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Controlrad, Inc. devices

FDA 510(k) Submission Details - K183109

510(k) Number K183109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2018
Decision Date May 13, 2019
Days to Decision 186 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
79d slower than avg
Panel avg: 107d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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

Controlrad , Ltd.
Sasha Gelfand

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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