Skip to content

Kanteron Dicom Station Kds Model 3.0

by Monica Veytia

510(k) K073176

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 NumberK073176 Date19 Mar 2008ClearedStatusActive

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  • Withdrawn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, 26 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 Kanteron Dicom Station (KDS), Model 3.0 is a software device intended for viewing images acquired from computer tomography (CT), magnetic resonance (MR), computed radiography (CR), digital radiography (DR), ultrasound (US), and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems.

The device runs on Apple Mac OSX systems and provides high performance review, navigation, and post processing functionality for multidimensional and multimodality images. It received FDA 510(k) clearance under K073176 on March 19, 2008, and is classified under product code LLZ with advisory committee review in radiology (RA).

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Kanteron Dicom Station (KDS), Model 3.0 used for?

    The Kanteron Dicom Station (KDS), Model 3.0 is intended for viewing images acquired from CT, MR, CR, DR, ultrasound and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware, enabling review, navigation and post processing of multidimensional and multimodality images.

  • What type of device is the Kanteron Dicom Station (KDS), Model 3.0 and what platform does it run on?

    The Kanteron Dicom Station (KDS), Model 3.0 is a software device designed to run on Apple Mac OSX systems, providing high performance functionality for medical image review and processing when installed on suitable commercial standard hardware.

  • What regulatory clearance does the Kanteron Dicom Station (KDS), Model 3.0 have and under what product code is it classified?

    The Kanteron Dicom Station (KDS), Model 3.0 received FDA 510(k) clearance under K073176 on March 19, 2008, and is classified under product code LLZ with advisory committee review in radiology (RA).