# K034059: Sectra Angiography Package and Sectra Cardiology Package

- Pathway: 510(k) (Traditional)
- Applicant: Sectra AB
- Decided: Mar 9, 2004 after 69 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: 4 generations back to K896095 (1990). 9 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K993761: Cardiovascular Measurement System - View, Medis Medical Imaging Systems BV (1999) Summary page 1.
- K993763: Quantitative Analysis of Coronary Angiograms (Qca), Medis Medical Imaging Systems BV (1999) Summary page 1.
- K993765: Quantitative Analysis of Left Ventricular Angiograms (QLV), Medis Medical Imaging Systems BV (1999) Summary page 1.
- K023970: Quantitative Vascular Angiography - CMS, Medis Medical Imaging Systems BV (2003) Summary page 1.

## Most influential descendants
- K042781: Ipacs Cardio (2004), 1 descendant of its own
- K082706: Infinitt Cardiology Pacs (2008), 0 descendants of its own

## Indications for use
The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs. This information is suitable for use in the following applications: 1. Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics, 2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators. Typical users of the device are trained professionals, e.g. physicians, radiologists, cardiologists and scientists.

Source page: https://510kreport.com/device/K034059
Methodology: https://510kreport.com/methodology