Cleared Traditional

MM-22 MICROTRON, MM50 MICROTRON (K900434) - FDA 510(k) Clearance

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

K900434 · Scanditronix, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
266d
Days
Class 2
Risk

K900434 is an FDA 510(k) clearance for the MM-22 MICROTRON, MM50 MICROTRON. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Scanditronix, Inc. (Essex, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Scanditronix, Inc. devices

Submission Details

510(k) Number K900434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date October 23, 1990
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 107d · This submission: 266d
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 211
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K900434.
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