Cleared Traditional

K913478 - RADIOGRAPHIC FILM MARKING SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K913478 · Lorad Medical Systems, Inc. · Radiology device
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Oct 1991
Decision
70d
Days
Class 1
Risk

K913478 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM MARKING SYSTEM. Classified as System, X-ray, Film Marking, Radiographic (product code JAC), Class I - General Controls.

Submitted by Lorad Medical Systems, Inc. (Danbury, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 70 days - a notably fast clearance cycle.

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: 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 Lorad Medical Systems, Inc. devices

Submission Details

510(k) Number K913478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date October 15, 1991
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
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.