Cleared Traditional

K030690 - CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS

K030690 is an FDA 510(k) clearance for CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS, manufactured by Codonics, Inc.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K030690 · Codonics, Inc. · Radiology device
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Apr 2003
Decision
56d
Days
Class 2
Risk

K030690 is an FDA 510(k) clearance for the CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS. 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 April 30, 2003 after a review of 56 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. 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 Codonics, Inc. devices

FDA 510(k) Submission Details - K030690

510(k) Number K030690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2003
Decision Date April 30, 2003
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LMC Camera, Multi Format, Radiological

All 56
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K030690.
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