Cleared Traditional

K915365 - AP-6CR CINERADIOGRAPHIC FILM PROCESSOR

K915365 is an FDA 510(k) clearance for AP-6CR CINERADIOGRAPHIC FILM PROCESSOR, 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 274-day FDA review.

K915365 · The Allen Products Co. · Radiology device
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Aug 1992
Decision
274d
Days
Class 2
Risk

K915365 is an FDA 510(k) clearance for the AP-6CR CINERADIOGRAPHIC FILM PROCESSOR. Classified as Processor, Cine Film (product code IXX), Class II - Special Controls.

Submitted by The Allen Products Co. (Milford, US). The FDA issued a Cleared decision on August 27, 1992 after a review of 274 days - an extended review cycle.

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 - K915365

510(k) Number K915365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date August 27, 1992
Days to Decision 274 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 107d · This submission: 274d
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.