Cleared Traditional

K960338 - STEREOTACTIC BODY FRAME

K960338 is the FDA 510(k) clearance for STEREOTACTIC BODY FRAME by Elekta Instrument AB. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K960338 · Elekta Instrument AB · Radiology device
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Apr 1996
Decision
90d
Days
Class 2
Risk

K960338 is an FDA 510(k) clearance for the STEREOTACTIC BODY FRAME. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Elekta Instrument AB (San Diego, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 90 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 Elekta Instrument AB devices

Submission Details

510(k) Number K960338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1996
Decision Date April 23, 1996
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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

All 303
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K960338.
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