# K200663: ControlRad Trace Model 9

- Pathway: 510(k) (Traditional)
- Applicant: Controlrad, Inc.
- Decided: Jun 24, 2020 after 103 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: 7 generations back to K021049 (2002). 8 ancestors in all.
3 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)
- K183109: ControlRad Trace Model 8, Controlrad, Inc. (2019) Summary page 4.

## Most influential descendants
- K202431: ControlRad Select Model Z (2020), 2 descendants of its own
- 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 ControlRadTM Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace’s region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area.1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite’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 cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. 1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Source page: https://510kreport.com/device/K200663
Methodology: https://510kreport.com/methodology