Cleared Traditional

K852804 - MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS

K852804 is an FDA 510(k) clearance for MEDCYC SUPERCONDUCT ISOCEN NEUTRON THER..., manufactured by Medcyc. Corp.. The device is a Class 2 Radiology device with product code IWL cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K852804 · Medcyc. Corp. · Radiology device
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Oct 1985
Decision
104d
Days
Class 2
Risk

K852804 is an FDA 510(k) clearance for the MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS. Classified as System, Radiation Therapy, Neutron, Medical (product code IWL), Class II - Special Controls.

Submitted by Medcyc. Corp. (East Lansing, US). The FDA issued a Cleared decision on October 15, 1985 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5300 - 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 Medcyc. Corp. devices

FDA 510(k) Submission Details - K852804

510(k) Number K852804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1985
Decision Date October 15, 1985
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWL Device Classification - Class 2, Special Controls

Product Code IWL System, Radiation Therapy, Neutron, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5300
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.