Cleared Traditional

K051483 - KODAK DIRECTVIEW DR SYSTEM DETECTOR

K051483 is an FDA 510(k) clearance for KODAK DIRECTVIEW DR SYSTEM DETECTOR, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K051483 · Eastman Kodak Company · Radiology device
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Jun 2005
Decision
15d
Days
Class 2
Risk

K051483 is an FDA 510(k) clearance for the KODAK DIRECTVIEW DR SYSTEM DETECTOR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on June 21, 2005 after a review of 15 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. 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.

View all Eastman Kodak Company devices

FDA 510(k) Submission Details - K051483

510(k) Number K051483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2005
Decision Date June 21, 2005
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 398
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K051483.
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K052136 · Anrad Corp. · Aug 2005
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K042791 · Ann Arbor Digital Devices · Jul 2005
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K051418 · Konica Minolta Medical & Graphic, Inc. · Jul 2005
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DDRCOMBI TRAUMA
K050718 · Swissray International, Inc. · May 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
K050987 · Canon, Inc. · Apr 2005