Cleared Traditional

K963334 - JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 (FDA 510(k) Clearance)

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

K963334 · Jamieson Film Co. · Radiology device
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Sep 1996
Decision
16d
Days
Class 2
Risk

K963334 is an FDA 510(k) clearance for the JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100. Classified as Processor, Cine Film (product code IXX), Class II - Special Controls.

Submitted by Jamieson Film Co. (Dallas, US). The FDA issued a Cleared decision on September 11, 1996 after a review of 16 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jamieson Film Co. devices

Submission Details

510(k) Number K963334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date September 11, 1996
Days to Decision 16 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.