Cleared Traditional

UNI-FRAME HEAD IMMOBILIZATION SYSTEM (K933227) - FDA 510(k) Clearance

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

K933227 · Medtec, Inc. · Radiology device
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Jul 1994
Decision
381d
Days
Class 2
Risk

K933227 is an FDA 510(k) clearance for the UNI-FRAME HEAD IMMOBILIZATION SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medtec, Inc. devices

Submission Details

510(k) Number K933227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1993
Decision Date July 18, 1994
Days to Decision 381 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
274d slower than avg
Panel avg: 107d · This submission: 381d
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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