# K112720: Mckesson Horizon Cardiology

- Pathway: 510(k) (Traditional)
- Applicant: Mckesson Israel, Ltd.
- Decided: Jan 30, 2012 after 133 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: 6 generations back to K842308 (1984). 32 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974679: The TCS-Medcon's Telecardiology System, Medcon, Ltd. (1998) Summary page 1.
- K061995: Xcelera, Philips Medical Systems North America Co. (2006) Summary page 1.
- K063628: Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy, Ge Healthcare Integrated IT Solutions (2006) Summary page 1.

## Most influential descendants
- K151850: McKesson Cardiology (2015), 2 descendants of its own
- K181080: McKesson Cardiology (2018), 1 descendant of its own
- K212528: Change Healthcare Cardiology (2021), 0 descendants of its own

## Indications for use
Horizon Cardiology Tm is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images. Horizon Cardiology Tm is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and may be part of a larger PACS configuration. Horizon Cardiology TM offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.

Source page: https://510kreport.com/device/K112720
Methodology: https://510kreport.com/methodology