Cleared Traditional

K837152 - THERAC 25 LINEAR ACCELERATOR

K837152 is an FDA 510(k) clearance for THERAC 25 LINEAR ACCELERATOR, manufactured by Atomic Energy of Canada. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K837152 · Atomic Energy of Canada · Radiology device
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Mar 1983
Decision
387d
Days
Class 2
Risk

K837152 is an FDA 510(k) clearance for the THERAC 25 LINEAR ACCELERATOR. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Atomic Energy of Canada (Kanata, Ontario, Canada, CA). The FDA issued a Cleared decision on March 22, 1983 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5770 - 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 Atomic Energy of Canada devices

FDA 510(k) Submission Details - K837152

510(k) Number K837152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1982
Decision Date March 22, 1983
Days to Decision 387 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
280d slower than avg
Panel avg: 107d · This submission: 387d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAI Device Classification - Class 2, Special Controls

Product Code JAI Couch, Radiation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5770
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.