510(k) · Cleared
ClearedHealthMyne PACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthmyne, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 20, 2015 as substantially equivalent to K043146 (Mckesson Medical Imaging Company, 2005) after a 15-day review. Its family tree reaches back 3 generations to 1993. 7 later devices descend from it.
- Decided
- Aug 20, 2015
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922164 (1993). 7 ancestors in all, the oldest K920319 (1992). 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 2 generations backK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- 1 generation backK043146 Horizon Medical ImagingMckesson Medical Imaging Company · 2005 · Recalled
- This deviceK152186 HealthMyne PACSHealthmyne, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK171544 Arterys ViewerArterys, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK182034 Arterys MICAArterys, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK192437 Arterys MICAArterys, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK203744 Arterys MICAArterys, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK211257 EFAI PACS Picture Archiving and Communication SystemEver Fortune.Ai, Co., Ltd. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171544Arterys ViewerArterys, Inc. · 2017 · cites it directly6descendants
- K182034Arterys MICAArterys, Inc. · 2018 · 2 generations on3descendants
- K192437Arterys MICAArterys, Inc. · 2020 · 3 generations on2descendants
- K203744Arterys MICAArterys, Inc. · 2022 · 4 generations on1descendant
- K211257EFAI PACS Picture Archiving and Communication SystemEver Fortune.Ai, Co., Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −2 | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software | Olicon Imaging Systems, Inc. | 1997 | — |
| −1 | K043146 | Horizon Medical Imaging | Mckesson Medical Imaging Company | 2005 | 11 |
| 0 (this device) | K152186 | HealthMyne PACS | Healthmyne, Inc. | 2015 | — |
| +1 | K171544 | Arterys Viewer | Arterys, Inc. | 2017 | — |
| +2 | K182034 | Arterys MICA | Arterys, Inc. | 2018 | — |
| +3 | K192437 | Arterys MICA | Arterys, Inc. | 2020 | — |
| +4 | K203744 | Arterys MICA | Arterys, Inc. | 2022 | — |
| +2 | K211257 | EFAI PACS Picture Archiving and Communication System | Ever Fortune.Ai, Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K043146 | Horizon Medical ImagingSummary page 4…e compatible with the DICOM standard. It performs functions similar to those currently available in the Horizon Medical Imaging software cleared for marketing via 510(k) K043146 by McKesson Medical Imaging Company. Device Description HealthMyne PACS accesses the information in real-time so that current pa… | 2005 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171544 | Arterys Viewer | 2017 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K171544 (Arterys, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K043146.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The HealthMyne PACS software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, with the exception of mammography. It provides the…
Read the full statement (146 words)
The HealthMyne PACS software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152186: HealthMyne PACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152186
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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