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Kodak Ektascan Image Transmission Syst T1/R1 Sftwr

by Eastman Kodak Company

510(k) K874778

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874778 Date23 Feb 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LMA
Device Class
Class II
Regulation
21 CFR Part 892.2030
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Ektascan Image Transmission System T1/R1 Software is a radiological image digitizer designed for transmitting radiographic images. It facilitates the conversion and transfer of analog film-based medical images into digital format, enabling integration with radiology information systems (RIS) and picture archiving and communication systems (PACS).

This software is supplied as a standalone application for use in radiology departments, supporting the transmission of digitized images from Kodak Ektascan systems. It operates as a Class II medical device under FDA 510(k) clearance (K874778), with a traditional review pathway and no third-party involvement. The system is intended for single-use or multi-use within controlled environments, adhering to regulatory standards for radiological imaging equipment.

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