# K052411: Hipax Medical Imaging Software

- Pathway: 510(k) (Traditional)
- Applicant: Steinhart Medizinsysteme GmbH
- Decided: Sep 21, 2005 after 23 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: 4 generations back to K896095 (1990). 5 ancestors in all.
80 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962699: Radworks Medical Imaging Software, Applicare Medical Imaging, B.V. (1996) Summary page 1.
- K012211: Efilm Workstation, Efilm Medical, Inc. (2001)

## Most influential descendants
- K070618: Dicompacs, Model 5 (2007), 78 descendants of its own
- K091364: Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 (2009), 58 descendants of its own
- K110033: Feel-DRCS (2011), 16 descendants of its own
- K101517: Sedecal Mobile Digital Diagnostic X-Ray (2011), 16 descendants of its own
- K110040: Omnivision (2011), 15 descendants of its own

## Indications for use
The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, DR, CT, MRI, US, RF units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system. Users of the Hipax Medical Imaging Software are typically trained medical professionals, for example, radiologists, orthopedists, clinicians, technologists, and others.

Source page: https://510kreport.com/device/K052411
Methodology: https://510kreport.com/methodology