# K200435: Catalyst+, Catalyst+ HD

- Pathway: 510(k) (Traditional)
- Applicant: C-Rad Positioning AB
- Decided: May 7, 2020 after 73 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864886 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113276: Catalyst, C-Rad Positioning AB (2012) Summary page 4.

## Recalls of this device
- Oct 9, 2025 · Class II · Z-1092-2026: Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly
- Apr 22, 2025 · Class II · Z-1858-2025: Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

## Indications for use
The Catalyst+ system and accessories are intended for use in radiation therapy clinics with treatment equipment, to provide: • Interactive guidance for setup and positioning of patients for radiation therapy • Intra-fraction motion detection during radiation therapy • Respiratory gating during radiation therapy The device is not intended for use in MR-linac systems. The system shall only be used by hospital personnel, qualified to work in radiation therapy departments. Training on the use of the system will be given to users at the time of installation.

Source page: https://510kreport.com/device/K200435
Methodology: https://510kreport.com/methodology