Cleared Traditional

K841431 - RADIOGRAPHIC FILM PROCESSOR M-30CR &

K841431 is an FDA 510(k) clearance for RADIOGRAPHIC FILM PROCESSOR M-30CR &, manufactured by The Allen Products Co.. The device is a Class 2 Radiology device with product code IXX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K841431 · The Allen Products Co. · Radiology device
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Jul 1984
Decision
91d
Days
Class 2
Risk

K841431 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM PROCESSOR M-30CR &. Classified as Processor, Cine Film (product code IXX), Class II - Special Controls.

Submitted by The Allen Products Co. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 The Allen Products Co. devices

FDA 510(k) Submission Details - K841431

510(k) Number K841431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date July 06, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXX Device Classification - Class 2, Special Controls

Product Code IXX Processor, Cine Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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.