# K043146: Horizon Medical Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Mckesson Medical Imaging Company
- Decided: Jan 4, 2005 after 50 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922164 (1993). 6 ancestors in all.
27 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925965: Picture Archiving and Communication Systems, Advanced Light Imaging Technologies, Ltd. (1993) Summary page 1.
- K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software, Olicon Imaging Systems, Inc. (1997) Summary page 1.
- K023557: Centricity Pacs Plus, GE Medical Systems (2002) Summary page 1.

## Most influential descendants
- K051649: Vericis Cardiovascular Image and Information System, Model 4.0 (2005), 10 descendants of its own
- K152186: HealthMyne PACS (2015), 7 descendants of its own
- K053133: Syngo Dynamics, Version 5.0 (2005), 7 descendants of its own
- K171544: Arterys Viewer (2017), 6 descendants of its own
- K111319: Ibis Explorer and Markup Software (2011), 6 descendants of its own

## Recalls of this device
- Jul 12, 2016 · Class II · Z-2872-2016: The STAT priority icon was not displayed in the Study List when the study was opened.
- Feb 18, 2016 · Class II · Z-1182-2016: McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a
- May 29, 2014 · Class II · Z-1728-2014: Firm received a complaint that an unreported study performed that day could not be opened from the archive.
- May 5, 2014 · Class II · Z-2121-2014: The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
- Apr 17, 2014 · Class II · Z-1617-2014: High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the 
- Dec 23, 2013 · Class II · Z-0976-2014: Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
- Oct 15, 2013 · Class II · Z-0556-2014: When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.
- Sep 4, 2013 · Class II · Z-2318-2013: Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
- May 29, 2012 · Class II · Z-2238-2012: There is a potential to save reports in RadReport with an Incorrect Final Status.
- Feb 2, 2011 · Not classified · Z-3035-2011: Images for one patient may appear in the study of another patient.
- May 7, 2010 · Not classified · Z-1735-2010: Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.

## Indications for use
Horizon Medical Imaging is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACRJNEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to connect to a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. 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 megapixel resolution and meets other technical specifications reviewed and approved by FDA. Horizon Medical Imaging will simply perform normal image manipulations for grayscale and image contrast on mammographic images and will not perform image processing on mammographic images. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft-copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft-copy diagnostic interpretation of mammographic images).

Source page: https://510kreport.com/device/K043146
Methodology: https://510kreport.com/methodology