# K022188: Radianalyzer, Model 12710

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Oct 3, 2002 after 90 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: 3 generations back to K003122 (2001). 6 ancestors in all.
46 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013943: Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720, Radi Medical Systems AB (2001)
- K002067: Radianalyzer, Model 12710, Radi Medical Systems AB (2001) Summary page 1.
- K020127: Smartflow Pulse Transmission Coefficient, Florence Medical, Ltd. (2002)
- K021048: Thermometer Models ST8631, Z7 International (2002)

## Most influential descendants
- K042628: Modification to: Radianalyzer, Model 12711 (2005), 26 descendants of its own
- K031662: Pressure Wire Sensor, Models 12004/12304 (2003), 26 descendants of its own
- K092105: Radianalyzer Xpress (2009), 25 descendants of its own
- K062769: Pressurewire Certus, Models 12006 and 12306 (2006), 25 descendants of its own
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver (2008), 13 descendants of its own

## Indications for use
RADIAnalyzerTM is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. RADIAnalyzerTM is intended for use in catheterization and related cardiovascular specially 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/K022188
Methodology: https://510kreport.com/methodology