Cleared Traditional

KONICA LD-4500 LASER DIGITIZER (K933830) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Konica Medical Corp. devices

Submission Details

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.

Device Classification

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

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