# K152186: HealthMyne PACS

- Pathway: 510(k) (Traditional)
- Applicant: Healthmyne, Inc.
- Decided: Aug 20, 2015 after 15 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: 3 generations back to K922164 (1993). 7 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043146: Horizon Medical Imaging, Mckesson Medical Imaging Company (2005) Summary page 4.

## Most influential descendants
- K171544: Arterys Viewer (2017), 6 descendants of its own
- K182034: Arterys MICA (2018), 3 descendants of its own
- K192437: Arterys MICA (2020), 2 descendants of its own
- K203744: Arterys MICA (2022), 1 descendant of its own
- K211257: EFAI PACS Picture Archiving and Communication System (2021), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K152186
Methodology: https://510kreport.com/methodology