Cleared Traditional

K920769 - KONICA LI 10 AND 10A LASER IMAGER

K920769 is an FDA 510(k) clearance for KONICA LI 10 AND 10A LASER IMAGER, manufactured by Konica Corp.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920769 · Konica Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
90d
Days
Class 2
Risk

K920769 is an FDA 510(k) clearance for the KONICA LI 10 AND 10A LASER IMAGER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Konica Corp. (New York, US). The FDA issued a Cleared decision on May 6, 1992 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Konica Corp. devices

FDA 510(k) Submission Details - K920769

510(k) Number K920769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1992
Decision Date May 06, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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 63
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K920769.
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
K922411 · Eastman Kodak Company · Aug 1992
MP3000 SERIES III VIDEO IMAGER
K921992 · International Imaging Electronics · Jul 1992
KODAK EKTASCAN 2180 LASER PRINTER
K921743 · Eastman Kodak Company · Jul 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