Cleared Traditional

K924345 - RADIOGRAPHIC FILM MARKETING SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K924345 · Fischer Imaging Corp. · Radiology device
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Nov 1992
Decision
92d
Days
Class 1
Risk

K924345 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM MARKETING SYSTEM. Classified as System, X-ray, Film Marking, Radiographic (product code JAC), Class I - General Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on November 27, 1992 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1640 - 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 Fischer Imaging Corp. devices

Submission Details

510(k) Number K924345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date November 27, 1992
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAC System, X-ray, Film Marking, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.