Cleared Traditional

K933830 - KONICA LD-4500 LASER DIGITIZER

K933830 is an FDA 510(k) clearance for KONICA LD-4500 LASER DIGITIZER, manufactured by Konica Medical Corp.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K933830 · Konica Medical Corp. · Radiology device
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Dec 1993
Decision
131d
Days
Class 2
Risk

K933830 is an FDA 510(k) clearance for the KONICA LD-4500 LASER DIGITIZER. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Konica Medical Corp. (New York, US). The FDA issued a Cleared decision on December 14, 1993 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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.

FDA 510(k) Submission Details - K933830

510(k) Number K933830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1993
Decision Date December 14, 1993
Days to Decision 131 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
24d slower than avg
Panel avg: 107d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

All 60
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K933830.
CEMAX SCANLINK V
K943357 · Cemax, Inc. · Nov 1994
DFS-2100
K932760 · Dba Systems, Inc. · Oct 1994
AD/V A.5
K925799 · Adaptive Video, Inc. · Feb 1994
MEDSCAN 12
K933632 · Vidar Systems Corp. · Dec 1993
LUMISCAN 50
K933129 · Lumisys, Inc. · Oct 1993
KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE
K925721 · Eastman Kodak Company · Feb 1993
K933830 · KONICA LD-4500 LASER DIGITIZER
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