# K043412: Modification to: Viewstation

- Pathway: 510(k) (Special)
- Applicant: Impac Medical Systems, Inc.
- Decided: Dec 20, 2004 after 10 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: 2 generations back to K942346 (1995). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011694: Viewstation, Impac Medical Systems, Inc. (2001) Summary page 2.
- K942346: Imagert, Impac Medical Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K120067: Mosaiq Oncology Information System (2012), 8 descendants of its own
- K142142: Quality Reports (2014), 5 descendants of its own
- K162468: ClearCheck (2016), 4 descendants of its own
- K220583: ClearCheck Model RADCC V2 (2022), 3 descendants of its own
- K231185: MapRT (2023), 1 descendant of its own

## Indications for use
ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis. The intended use of ViewStation is to provide health care facility personnel with an efficient and effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions.

Source page: https://510kreport.com/device/K043412
Methodology: https://510kreport.com/methodology