# K142891: Hepatiq

- Pathway: 510(k) (Traditional)
- Applicant: Hepatiq, LLC
- Decided: Dec 17, 2014 after 75 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 K892358 (1989). 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)
- K993946: Pegasys Ultra, Adac Laboratories (2000) Summary page 5.

## Indications for use
HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images. The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images. The data processed may be derived from any nuclear medicine liver-spleen procedure. The HEPATIQ software should only be used by qualified nuclear medicine professionals.

Source page: https://510kreport.com/device/K142891
Methodology: https://510kreport.com/methodology