Cleared Traditional

K984466 - DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5

K984466 is an FDA 510(k) clearance for DILON 2000, manufactured by Dilon Technologies, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K984466

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.

IYX Device Classification - Class 1, General Controls

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.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 70
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K984466.
Discovery NM 750b Bopsy
K160933 · Ge Healthcare · Nov 2016
ERGO IMAGING SYSTEM
K123408 · Digirad Corp. · Jan 2013
ERGO IMAGING SYSTEM
K100838 · Digirad Corp. · Apr 2010
NOTEBOOK IMAGER
K961104 · Digirad Corp. · May 1997
APEX SPX CARDIAL
K932673 · Elscint, Inc. · Feb 1994
CARBON FIBER PALLET
K934766 · Siemens Gammasonics, Inc. · Feb 1994