Cleared Traditional

RADIATION TREATMENT FOR CANCER PATIENTS (K930182) - FDA 510(k) Clearance

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

K930182 · Northwest Medical Physics Center · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
356d
Days
Class 2
Risk

K930182 is an FDA 510(k) clearance for the RADIATION TREATMENT FOR CANCER PATIENTS. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Northwest Medical Physics Center (Lynnwood, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 356 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 Northwest Medical Physics Center devices

Submission Details

510(k) Number K930182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date January 05, 1994
Days to Decision 356 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 107d · This submission: 356d
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 204
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K930182.
TARGET 2 VERSION 1.1
K965010 · GE Medical Systems · Jul 1997
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM
K962950 · Varian Medical Systems, Inc. · Jul 1997
KODAK EC-L CASSETTE
K960834 · Eastman Kodak Company · May 1996
SATURNE 41
K892860 · General Electric Co. · Jun 1989
SATURNE 42 AND 43
K883019 · General Electric Co. · Nov 1988