# K153289: Healthmyne

- Pathway: 510(k) (Traditional)
- Applicant: Healthmyne, Inc.
- Decided: Jan 15, 2016 after 63 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: 12 generations back to K913770 (1991). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121213: Vitreaadvanced, Vital Images, Inc. (2012) Summary page 4.

## Indications for use
The HealthMyne 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 software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the HL7 and DICOM (including DICOM-RT) standards, 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, and export the information. The product automatically and semi-automatically segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures. 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 (for example, image analysis) 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/K153289
Methodology: https://510kreport.com/methodology