# K113276: Catalyst

- Pathway: 510(k) (Traditional)
- Applicant: C-Rad Positioning AB
- Decided: Feb 27, 2012 after 112 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864886 (1987). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082582: Sentinel, Model SP-001, C-Rad Positioning AB (2009) Summary page 1.
- K072171: Gatect-RT, Vision RT Limited (2007) Summary page 1.

## Most influential descendants
- K241937: Klarity SGRT System (ARSG-E1A, ARSG-E3A) (2025), 0 descendants of its own
- K200435: Catalyst+, Catalyst+ HD (2020), 0 descendants of its own

## Recalls of this device
- Aug 6, 2020 · Class II · Z-2075-2021: PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

## Indications for use
The Catalyst system is intended for use in radiation therapy clinics to accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment. The system provides. information about a patient's position and the adjustments required inorder to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment and. disables the treatment beam in case of large detected movements. The system can also track the patient's respiratory motion for supporting synchronized image acquisition or treatment delivery. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments.

Source page: https://510kreport.com/device/K113276
Methodology: https://510kreport.com/methodology