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Kodak Digital Science Medical Printer Interface Unit

by Kodak Health Imaging Systems, Inc.

510(k) K961740

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961740 Date14 Nov 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kodak Digital Science Medical Printer Interface Unit is a system for image processing in radiology. It functions as a component of a PACS and connects medical imaging systems such as CT or MRI machines to printers. The device accepts inputs from medical imaging modalities via monochrome (RS-170/CCIR) or RGB video signals.

It enables the production of hard copies of diagnostic images for patient records and clinical analysis by translating digital images into printed output. The unit was cleared through the FDA 510(k) process under K961740 and is classified in the LLZ product code. It is supplied as a non-sterile, reusable device for use in radiological settings.

Other devices from Kodak Health Imaging Systems, Inc.