Cleared Traditional

K922079 - ROTOLUX, SELECTOLUX, SHUTTERVUE

K922079 is an FDA 510(k) clearance for ROTOLUX, manufactured by American Medical Sales, Inc.. The device is a Class 1 Radiology device with product code IXC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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.

FDA 510(k) Submission Details - K922079

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

IXC Device Classification - Class 1, General Controls

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.

Regulatory Peers - IXC Illuminator, Radiographic-film

All 14
Devices cleared under the same product code (IXC) and FDA review panel - the closest regulatory comparables to K922079.
VOXBOX
K954199 · Voxel · Sep 1995
ADVIEWER 2000
K952188 · Adp , Ltd. · May 1995
ULTRALITE X-RAY FILM ILLUMINATOR
K922848 · A & S Trading Co. · Sep 1992
EXCELVIEW ILLUMINATOR
K883702 · Excel Medical Products, Inc. · Sep 1988
VARIVIEWER (X-RAY FILM VIEWER)
K875233 · Diversified Diagnostic Products, Inc. · Jan 1988
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
K872245 · General Electric Co. · Jun 1987
K922079 · ROTOLUX, SELECTOLUX, SHUTTERVUE
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