Cleared Traditional

K161984 - Interlocked Circular Small Field Collimators, Elekta Integrated

K161984 is an FDA 510(k) clearance for Interlocked Circular Small Field Collim..., manufactured by Aktina Medical Corporation. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K161984 · Aktina Medical Corporation · Radiology device
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Sep 2016
Decision
70d
Days
Class 2
Risk

K161984 is an FDA 510(k) clearance for the Interlocked Circular Small Field Collimators, Elekta Integrated. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Aktina Medical Corporation (Congers, US). The FDA issued a Cleared decision on September 27, 2016 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aktina Medical Corporation devices

FDA 510(k) Submission Details - K161984

510(k) Number K161984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2016
Decision Date September 27, 2016
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
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 530
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