# K220311: Cardiovascular Angiography System

- Pathway: 510(k) (Traditional)
- Applicant: Allengers Medical Systems Limited
- Decided: May 3, 2022 after 90 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K801623 (1980). 55 ancestors in all.
No later device cites it as a predicate yet.
2 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162859: Allura Xper FD series and Allura Xper OR Table series, Philips Medical Systems Nederland B.V. (2016) Summary page 4.

## Indications for use
The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body. Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations. This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance. Exclusion: This system is not recommended for Mammography. Contraindication: Exposure of X-Ray should be avoided during pregnancy.

Source page: https://510kreport.com/device/K220311
Methodology: https://510kreport.com/methodology