# K260231: MiPACS V5 (1.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Apryse Software Corp
- Decided: Jun 25, 2026 after 150 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: 2 generations back to K182572 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212984: MiPACS HTML5 Web Viewer, Lead Technologies, Inc. (2021) Summary page 5.

## Indications for use
MiPACS V5 is a software-only medical and dental DICOM image viewing system with integrated image acquisition functionality. MiPACS V5 is intended for use by trained healthcare professionals for the acquisition, viewing, manipulation, and management of medical and dental images in DICOM format. MiPACS V5 is not intended to replace primary diagnostic workstations and does not provide automated diagnosis, image interpretation, or clinical decision support.

Source page: https://510kreport.com/device/K260231
Methodology: https://510kreport.com/methodology