Cleared Traditional

K924345 - RADIOGRAPHIC FILM MARKETING SYSTEM

K924345 is an FDA 510(k) clearance for RADIOGRAPHIC FILM MARKETING SYSTEM, manufactured by Fischer Imaging Corp.. The device is a Class 1 Radiology device with product code JAC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K924345

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

JAC Device Classification - Class 1, General Controls

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.

Regulatory Peers - JAC System, X-ray, Film Marking, Radiographic

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