Cleared Traditional

K844180 - THE MCP-70-SE SYSTEM

K844180 is an FDA 510(k) clearance for THE MCP-70-SE SYSTEM, manufactured by Ellis Pharmaceutical Consulting, Inc.. The device is a Class 2 Radiology device with product code KQA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K844180 · Ellis Pharmaceutical Consulting, Inc. · Radiology device
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Feb 1985
Decision
98d
Days
Class 2
Risk

K844180 is an FDA 510(k) clearance for the THE MCP-70-SE SYSTEM. Classified as Device, Beam Limiting, X-ray, Therapeutic (product code KQA), Class II - Special Controls.

Submitted by Ellis Pharmaceutical Consulting, Inc. (Princeton, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Ellis Pharmaceutical Consulting, Inc. devices

FDA 510(k) Submission Details - K844180

510(k) Number K844180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1984
Decision Date February 01, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQA Device Classification - Class 2, Special Controls

Product Code KQA Device, Beam Limiting, X-ray, Therapeutic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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.