# K232032: Probeat-FR

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Decided: Jan 12, 2024 after 189 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K872369 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201042: Probeat-CR, Hitachi, Ltd. (2020) Summary page 5.

## Recalls of this device
- Feb 6, 2026 · Class II · Z-1429-2026: Software anomaly in the patient positioning system may result in positional discrepancy.
- May 27, 2024 · Class II · Z-3125-2024: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in numb
- May 27, 2024 · Class II · Z-3126-2024: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in numb
- May 27, 2024 · Class II · Z-3127-2024: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in numb

## Indications for use
The PROBEAT-FR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K232032
Methodology: https://510kreport.com/methodology