Cleared Special

K060292 - KODAK MODELS 2100 AND 2200

K060292 is an FDA 510(k) clearance for KODAK MODELS 2100 AND 2200, manufactured by Kodak-Trophy. The device is a Class 2 Radiology device with product code EHD cleared through the Special 510(k) pathway after a 25-day FDA review.

K060292 · Kodak-Trophy · Radiology device
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Mar 2006
Decision
25d
Days
Class 2
Risk

K060292 is an FDA 510(k) clearance for the KODAK MODELS 2100 AND 2200. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Kodak-Trophy (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on March 3, 2006 after a review of 25 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 - K060292

510(k) Number K060292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2006
Decision Date March 03, 2006
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
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 187
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K060292.
RX DC X-RAY UNIT
K080076 · Cefla S.C.R.L. · Mar 2008
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
K063121 · Genoray Co., Ltd. · Jan 2007
DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
K060640 · Dentamerica · Apr 2006
NOMAD DENTAL X-RAY SYSTEM
K051795 · Aribex, Inc. · Jul 2005
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
K051464 · Planmeca Oy · Jun 2005
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
K050255 · Gendex Dental Systems · Mar 2005
K060292 · KODAK MODELS 2100 AND 2200
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