Cleared Traditional

K922276 - THERAC 25

K922276 is an FDA 510(k) clearance for THERAC 25, manufactured by Theratronics, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 740-day FDA review.

K922276 · Theratronics, Inc. · Radiology device
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May 1994
Decision
740d
Days
Class 2
Risk

K922276 is an FDA 510(k) clearance for the THERAC 25. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Theratronics, Inc. (Kanata, Ontario, Canada, CA). The FDA issued a Cleared decision on May 25, 1994 after a review of 740 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

FDA 510(k) Submission Details - K922276

510(k) Number K922276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date May 25, 1994
Days to Decision 740 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
633d slower than avg
Panel avg: 107d · This submission: 740d
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 705
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K922276.
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K935021 · Medtec, Inc. · Apr 1994
ARM RADIATION BEAM SCANNER
K933558 · Advanced Radiation Measurements, Inc. · Mar 1994
K922276 · THERAC 25
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