Cleared Traditional

K914582 - KODAK EKTASCAN 1120 LASER PRINTER

K914582 is the FDA 510(k) clearance for KODAK EKTASCAN 1120 LASER PRINTER by Eastman Kodak Company. It is a Class 2 Radiology device (product code LMC) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K914582 · Eastman Kodak Company · Radiology device
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Dec 1991
Decision
64d
Days
Class 2
Risk

K914582 is an FDA 510(k) clearance for the KODAK EKTASCAN 1120 LASER PRINTER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on December 19, 1991 after a review of 64 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 Eastman Kodak Company devices

Submission Details

510(k) Number K914582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1991
Decision Date December 19, 1991
Days to Decision 64 days
Submission Type Traditional
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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K914582.
MATRIX CR 2050, PMI 3000
K925289 · Heraeus Kulzer, Inc. · Apr 1993
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
K922411 · Eastman Kodak Company · Aug 1992
KODAK EKTASCAN 2180 LASER PRINTER
K921743 · Eastman Kodak Company · Jul 1992
EAGLE SYSTEM
K912799 · Marquette Electronics, Inc. · Dec 1991
KODAK EKTASCAN CABLE EXTENSION
K911437 · Eastman Kodak Company · May 1991
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
K905566 · Eastman Kodak Company · Jan 1991