# K092105: Radianalyzer Xpress

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Oct 9, 2009 after 87 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: 5 generations back to K003122 (2001). 8 ancestors in all.
25 later devices descend from it; 8 cite 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)
- K042628: Modification to: Radianalyzer, Model 12711, Radi Medical Systems AB (2005) Summary page 1.
- K013943: Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720, Radi Medical Systems AB (2001)

## Most influential descendants
- 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
- K210889: iLab Polaris Multi-Modality Guidance System (2021), 4 descendants of its own

## Indications for use
RadiAnalyzer® Xpress is indicated to provide hemodynaimic information for use in the diagnosis and treatment of patients that undeigo measurement of physiological parameters with PressureWire®. RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow parameters based on the output from one or more electrodes, transducers or measuring devices.

Source page: https://510kreport.com/device/K092105
Methodology: https://510kreport.com/methodology