Cleared Traditional

K973965 - SMART MOTORIZED VIEWER (FDA 510(k) Clearance)

Class I Radiology device.

K973965 · Smartlight, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
56d
Days
Class 1
Risk

K973965 is an FDA 510(k) clearance for the SMART MOTORIZED VIEWER. Classified as Illuminator, Radiographic-film (product code IXC), Class I - General Controls.

Submitted by Smartlight, Ltd. (Nesher, IL). The FDA issued a Cleared decision on December 12, 1997 after a review of 56 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, Ltd. devices

Submission Details

510(k) Number K973965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1997
Decision Date December 12, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
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.