Cleared Traditional

K034051 - DYNATRAC, COD. 50-1A

K034051 is an FDA 510(k) clearance for DYNATRAC, manufactured by 3D Line USA, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K034051 · 3D Line USA, Inc. · Radiology device
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Apr 2004
Decision
97d
Days
Class 2
Risk

K034051 is an FDA 510(k) clearance for the DYNATRAC, COD. 50-1A. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by 3D Line USA, Inc. (Reston, US). The FDA issued a Cleared decision on April 5, 2004 after a review of 97 days - within the typical 510(k) review window.

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: 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 3D Line USA, Inc. devices

FDA 510(k) Submission Details - K034051

510(k) Number K034051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2003
Decision Date April 05, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
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 Peers - IYE Accelerator, Linear, Medical

All 476
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