Cleared Traditional

K904753 - DIOLASE (FDA 510(k) Clearance)

Class I Radiology device.

K904753 · Scanditronix, Inc. · Radiology device
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Nov 1990
Decision
21d
Days
Class 1
Risk

K904753 is an FDA 510(k) clearance for the DIOLASE. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Scanditronix, Inc. (Sweden, SE). The FDA issued a Cleared decision on November 9, 1990 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - 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 Scanditronix, Inc. devices

Submission Details

510(k) Number K904753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1990
Decision Date November 09, 1990
Days to Decision 21 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
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.