Cleared Traditional

K921743 - KODAK EKTASCAN 2180 LASER PRINTER

K921743 is the FDA 510(k) clearance for KODAK EKTASCAN 2180 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 79-day FDA review.

K921743 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
79d
Days
Class 2
Risk

K921743 is an FDA 510(k) clearance for the KODAK EKTASCAN 2180 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 July 1, 1992 after a review of 79 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 K921743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date July 01, 1992
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
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 K921743.
PHILIPS LASER DISK ARCHIVE
K923481 · Philips Medical Systems, Inc. · May 1993
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 1120 LASER PRINTER
K914582 · Eastman Kodak Company · Dec 1991
EAGLE SYSTEM
K912799 · Marquette Electronics, Inc. · Dec 1991
KODAK EKTASCAN CABLE EXTENSION
K911437 · Eastman Kodak Company · May 1991