# K143397: ICIS View

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Jun 1, 2015 after 187 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: 9 generations back to K954874 (1996). 42 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103785: Mobile Mim, Mim Software, Inc. (2011) Summary page 4.
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002) Summary page 4.
- K111164: Eunity, Client Outlook, Inc. (2011) Summary page 4.

## Most influential descendants
- K170434: Enterprise Imaging XERO Viewer 8.1 (2017), 3 descendants of its own
- K231662: Aid-U (2024), 1 descendant of its own
- K200822: Braid (2020), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own
- K250039: HPACS (2025), 0 descendants of its own

## Indications for use
ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer. Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and measurements (for example window/level, rotation, zoom, and markups). ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis.

Source page: https://510kreport.com/device/K143397
Methodology: https://510kreport.com/methodology