# K073176: Kanteron Dicom Station (KDS), Model 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Monica Veytia
- Decided: Mar 19, 2008 after 127 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942120 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063470: Aycan Workstation Osirix, Aycan Digitalsysteme GmbH (2007) Summary page 1.

## Indications for use
Kanteron DICOM Station (KDS) is a software device intended for viewing of 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. Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations, Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM 'for presentation" images must be used. Mammographic images must only be viewed with a monitor approved by the FDA for viewing mammographic images. It is the Users responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application. The KDS Is not intended for use as a preoperative surgical planning system and must not be used for this purpose.

Source page: https://510kreport.com/device/K073176
Methodology: https://510kreport.com/methodology