Cleared Special

K040556 - TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY

K040556 is an FDA 510(k) clearance for TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGIN..., manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code EHD cleared through the Special 510(k) pathway after a 36-day FDA review.

K040556 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
36d
Days
Class 2
Risk

K040556 is an FDA 510(k) clearance for the TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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.

FDA 510(k) Submission Details - K040556

510(k) Number K040556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date April 07, 2004
Days to Decision 36 days
Submission Type Special
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
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 190
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K040556 · TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
Download PDF FDA Summary Eastman Kodak Company