Cleared Traditional

STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 (K081935) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081935 · Aktina Medical Physics Corp. · Radiology device
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Oct 2008
Decision
92d
Days
Class 2
Risk

K081935 is an FDA 510(k) clearance for the STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Aktina Medical Physics Corp. (Congers, US). The FDA issued a Cleared decision on October 7, 2008 after a review of 92 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 Aktina Medical Physics Corp. devices

Submission Details

510(k) Number K081935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date October 07, 2008
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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