Cleared Special

K051258 - KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345

K051258 is an FDA 510(k) clearance for KODAK DIRECTVIEW DR 7500 SYSTEM, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 16-day FDA review.

K051258 · Eastman Kodak Company · Radiology device
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Jun 2005
Decision
16d
Days
Class 2
Risk

K051258 is an FDA 510(k) clearance for the KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on June 1, 2005 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 - K051258

510(k) Number K051258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date June 01, 2005
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 357
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K051258.
DDRFORMULA AND DDRFORMULA PLUS
K052943 · Swissray Medical AG · Dec 2005
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
K052541 · Avant Medical Systems · Nov 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
K051967 · Ge Healthcare · Aug 2005
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
K050704 · General Electric Co. · Apr 2005
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS
K033577 · Medlink Imaging · Mar 2005
MULTIDIAGNOST ELEVA
K050151 · Philips Medical Systems North America, Inc. · Feb 2005
K051258 · KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
Download PDF Eastman Kodak Company