Cleared Traditional

K110384 - DILON 6800 ACELLA (ACELLA)

K110384 is an FDA 510(k) clearance for DILON 6800 ACELLA (ACELLA), 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 82-day FDA review.

K110384 · Dilon Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
82d
Days
Class 1
Risk

K110384 is an FDA 510(k) clearance for the DILON 6800 ACELLA (ACELLA). Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Dilon Technologies, Inc. (Stillwater, US). The FDA issued a Cleared decision on May 3, 2011 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K110384

510(k) Number K110384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2011
Decision Date May 03, 2011
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
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 109
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K110384 · DILON 6800 ACELLA (ACELLA)
Download PDF FDA Summary Dilon Technologies, I…