# K082706: Infinitt Cardiology Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Nov 6, 2008 after 51 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: 6 generations back to K896095 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034059: Sectra Angiography Package and Sectra Cardiology Package, Sectra AB (2004) Summary page 1.
- K042781: Ipacs Cardio, Realtimeimage, Inc. (2004) Summary page 1.
- K051649: Vericis Cardiovascular Image and Information System, Model 4.0, Camtronics Medical Systems (2005) Summary page 1.

## Indications for use
INFINITT Cardiology PACS TM is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

Source page: https://510kreport.com/device/K082706
Methodology: https://510kreport.com/methodology