Cleared Traditional

K922079 - ROTOLUX, SELECTOLUX, SHUTTERVUE (FDA 510(k) Clearance)

Class I Radiology device.

K922079 · American Medical Sales, Inc. · Radiology device
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Jun 1992
Decision
43d
Days
Class 1
Risk

K922079 is an FDA 510(k) clearance for the ROTOLUX, SELECTOLUX, SHUTTERVUE. Classified as Illuminator, Radiographic-film (product code IXC), Class I - General Controls.

Submitted by American Medical Sales, Inc. (Culver City, US). The FDA issued a Cleared decision on June 16, 1992 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1890 - 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 American Medical Sales, Inc. devices

Submission Details

510(k) Number K922079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date June 16, 1992
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXC Illuminator, Radiographic-film
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1890
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.