# K202431: ControlRad Select Model Z

- Pathway: 510(k) (Traditional)
- Applicant: Controlrad, Inc.
- Decided: Dec 23, 2020 after 120 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: 8 generations back to K021049 (2002). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200663: ControlRad Trace Model 9, Controlrad, Inc. (2020) Summary page 5.

## Most influential descendants
- K213455: ControlRad Select Model Z (2021), 0 descendants of its own
- K211782: ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 (2021), 0 descendants of its own

## Indications for use
The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients’ and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z’s region of interest (ROI) as compared to Artis zee non-collimated image area.¹ The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee’s collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ¹Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

Source page: https://510kreport.com/device/K202431
Methodology: https://510kreport.com/methodology