Cleared Traditional

K984466 - DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 (FDA 510(k) Clearance)

Class I Radiology device.

K984466 · Dilon Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
90d
Days
Class 1
Risk

K984466 is an FDA 510(k) clearance for the DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Dilon Technologies, Inc. (Newport News, US). The FDA issued a Cleared decision on March 16, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dilon Technologies, Inc. devices

Submission Details

510(k) Number K984466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1998
Decision Date March 16, 1999
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
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.