Cleared Traditional

K012227 - MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

K012227 is an FDA 510(k) clearance for MUCHECK - MONITOR UNIT VALIDATION PROGRAM, manufactured by Oncology Data Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K012227 · Oncology Data Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
77d
Days
Class 2
Risk

K012227 is an FDA 510(k) clearance for the MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Oncology Data Systems, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on October 1, 2001 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K012227

510(k) Number K012227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date October 01, 2001
Days to Decision 77 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
30d faster than avg
Panel avg: 107d · This submission: 77d
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 704
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K012227.
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K012227 · MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
Download PDF FDA Summary Oncology Data Systems…