Cleared Traditional

K021054 - CODONICS HORIZON CI MEDICAL MULTIMEDIA ...

Also marketed or referenced as:
CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER

K021054 is an FDA 510(k) clearance for CODONICS HORIZON CI MEDICAL MULTIMEDIA ..., 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 38-day FDA review.

K021054 · Codonics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
38d
Days
Class 2
Risk

K021054 is an FDA 510(k) clearance for the CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER. 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 May 9, 2002 after a review of 38 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 - K021054

510(k) Number K021054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date May 09, 2002
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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
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