# K013943: Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720

- Pathway: 510(k) (Special)
- Applicant: Radi Medical Systems AB
- Decided: Dec 18, 2001 after 19 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002067 (2001). 1 ancestor in all.
47 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002067: Radianalyzer, Model 12710, Radi Medical Systems AB (2001) Summary page 1.

## Most influential descendants
- K022188: Radianalyzer, Model 12710 (2002), 46 descendants of its own
- 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

## Indications for use
The RadiAnalyzer is intended for use under the direction of a licensed physician to calculate, display and record vascular data. Data is acquired from a PressureWire Sensor and an External Pressure Transducer (EPT). The information is displayed on the integrated screen and/or transferred to a cardiac monitor. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). The RadiAnalyzer is intended for use in catheterization and related cardiovascular specially laboratories.

Source page: https://510kreport.com/device/K013943
Methodology: https://510kreport.com/methodology