Cleared Traditional

K991302 - SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS

K991302 is an FDA 510(k) clearance for SMARTLIGHT DIGITAL FILM VIEWER, manufactured by Smartlight, Inc.. The device is a Class 1 Radiology device with product code IXC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K991302 · Smartlight, Inc. · Radiology device
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Jun 1999
Decision
46d
Days
Class 1
Risk

K991302 is an FDA 510(k) clearance for the SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS. Classified as Illuminator, Radiographic-film (product code IXC), Class I - General Controls.

Submitted by Smartlight, Inc. (Hackensack, US). The FDA issued a Cleared decision on June 1, 1999 after a review of 46 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 Smartlight, Inc. devices

FDA 510(k) Submission Details - K991302

510(k) Number K991302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1999
Decision Date June 01, 1999
Days to Decision 46 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 107d · This submission: 46d
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

Devices cleared under the same product code (IXC) and FDA review panel - the closest regulatory comparables to K991302.
SMART MOTORIZED VIEWER
K973965 · Smartlight, Ltd. · Dec 1997
ARRIPRO 35 ST/TV
K973115 · Arnold & Richter Cine Technik · Sep 1997
DIFFUSER PANEL
K970240 · Focused Viewer, Inc. · Mar 1997
LILY DARK VIEWER
K954998 · Lily Imaging Solutions Co. · Jan 1996
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
K872245 · General Electric Co. · Jun 1987
LF MOTORIZED RADIOGRAPHIC FILM VIEWER
K840607 · Sybron Corp. · Mar 1984