510(k) · Cleared
Recalled · Class II · 2016Horizon Medical Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckesson Medical Imaging Company · LLZ System, Image Processing, Radiological
Cleared on Jan 4, 2005 as substantially equivalent to K925965 (Advanced Light Imaging Technologies, Ltd., 1993) and 2 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1993. 27 later devices descend from it. It has been recalled 11 times.
- Decided
- Jan 4, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922164 (1993). 6 ancestors in all, the oldest K920319 (1992). 27 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 1 generation backK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- This deviceK043146 Horizon Medical ImagingMckesson Medical Imaging Company · 2005
- Descendant · cites it directly · 10 of its ownK051649 Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems · 2005 · Recalled
- Descendant · cites it directly · 7 of its ownK152186 HealthMyne PACSHealthmyne, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK171544 Arterys ViewerArterys, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K051649Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems · 2005 · cites it directly10descendants
- K152186HealthMyne PACSHealthmyne, Inc. · 2015 · cites it directly7descendants
- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 2 generations on7descendants
- K171544Arterys ViewerArterys, Inc. · 2017 · 2 generations on6descendants
- K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −1 | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software | Olicon Imaging Systems, Inc. | 1997 | — |
| 0 (this device) | K043146 | Horizon Medical Imaging | Mckesson Medical Imaging Company | 2005 | — |
| +1 | K051649 | Vericis Cardiovascular Image and Information System, Model 4.0 | Camtronics Medical Systems | 2005 | 17 |
| +1 | K152186 | HealthMyne PACS | Healthmyne, Inc. | 2015 | — |
| +2 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| +2 | K171544 | Arterys Viewer | Arterys, Inc. | 2017 | — |
| +3 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K925965 | Picture Archiving and Communication SystemsSummary page 1…s System (per 21 CFR 892.2050). 5.3 Devices to which Substantial Equivalence is being Claimed 510(k) Number Device Name Manufacturer K925965 Picture Archiving and Advanced Light Imaging Technologies Communication Systems Inc.… | 1993 |
| * | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareSummary page 1…Light Imaging Technologies Communication Systems Inc. (now McKesson Medical Imaging Company) K973959 02 Workstation and/or Olicon Imaging Systems Inc. (now PACSView software McKesso… | 1997 |
| * | K023557 | Centricity Pacs PlusSummary page 1…y) K973959 02 Workstation and/or Olicon Imaging Systems Inc. (now PACSView software McKesson Medical Imaging Company) 1K023557 Centricity PACS Plus GE Medical Systems Horizon Medical Imaging is based on the above identified FDA cleared P… | 2002 |
What descends from it? (27)
See all 275 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2016 | Class II | Z-2872-2016 | Software design | The STAT priority icon was not displayed in the Study List when the study was opened. |
| Feb 18, 2016 | Class II | Z-1182-2016 | Software design | 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 patient. |
| May 29, 2014 | Class II | Z-1728-2014 | Software design | 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 | Software design | 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 | Software Design Change | 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 Study List. |
| Dec 23, 2013 | Class II | Z-0976-2014 | Software design | 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 | Other | 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 change control | 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 | Software design | There is a potential to save reports in RadReport with an Incorrect Final Status. |
| Feb 2, 2011 | Not classified | Z-3035-2011 | Other | Images for one patient may appear in the study of another patient. |
| May 7, 2010 | Not classified | Z-1735-2010 | Software design | 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. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K051649 (Camtronics Medical Systems, 2005) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K925965.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (211 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043146: Horizon Medical Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043146
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026