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Konica LD-4500 Laser Digitizer

by Konica Medical Corp. 510(k)

Active United States

510(k) K933830

Overview

The Konica LD-4500 Laser Digitizer is a medical image digitizer intended to convert analog medical images into a digital format. This device uses laser technology to scan and digitize radiological images for further processing and analysis.

The device is supplied by Konica Medical Corp. and is a Class II medical device that received FDA 510(k) clearance in 1993 under K-number K933830. It is used in radiology settings and is regulated under product code LMA. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933830 Date14 Dec 1993ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LMA
Device Class
Class II
Regulation
21 CFR Part 892.2030
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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