Cleared Traditional

K081935 - STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100

K081935 is an FDA 510(k) clearance for STEREOTACTIC HEAD AND NECK LOCALIZER, manufactured by Aktina Medical Physics Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K081935 · Aktina Medical Physics Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K081935

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
Combination Product No
PCCP Authorized No
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.

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 703
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K081935 · STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
Download PDF FDA Summary Aktina Medical Physic…