# K042628: Modification to: Radianalyzer, Model 12711

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Jan 19, 2005 after 114 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K003122 (2001). 7 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022188: Radianalyzer, Model 12710, Radi Medical Systems AB (2002) Summary page 1.

## Most influential descendants
- K092105: Radianalyzer Xpress (2009), 25 descendants of its own
- K151613: iLab Polaris Multi-Modality Guidance System (2015), 10 descendants of its own
- K191008: iLab Polaris Multi-Modality Guidance System (2019), 8 descendants of its own
- K201178: iLab Polaris Multi-Modality Guidance System (2020), 6 descendants of its own
- K123984: Quantien Measurement System (2013), 5 descendants of its own

## Indications for use
RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. RadiAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

Source page: https://510kreport.com/device/K042628
Methodology: https://510kreport.com/methodology