# K042781: Ipacs Cardio

- Pathway: 510(k) (Traditional)
- Applicant: Realtimeimage, Inc.
- Decided: Oct 19, 2004 after 13 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: 5 generations back to K896095 (1990). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K082706: Infinitt Cardiology Pacs (2008), 0 descendants of its own

## Indications for use
iPACS CARDIO TM is intended for the manipulation, displaying, and distribution of medical images. It can show 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 orthopedic surgeons, physicians, and radiologists.

Source page: https://510kreport.com/device/K042781
Methodology: https://510kreport.com/methodology