Cleared Special

K060440 - CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER (FDA 510(k) Clearance)

Also includes:
CODONICS HORIZON XL-X LONG FILM IMAGER

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060440 · Codonics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
23d
Days
Class 2
Risk

K060440 is an FDA 510(k) clearance for the CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Codonics, Inc. (Middleburg Heights, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Codonics, Inc. devices

Submission Details

510(k) Number K060440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2006
Decision Date March 16, 2006
Days to Decision 23 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.