# K152207: Extended Range Shifter for PROBEAT-V

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd., Health Care Company
- Decided: Oct 2, 2015 after 57 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K872369 (1988). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151132: Probeat-V, Hitachi, Ltd., Health Care Company (2015) Summary page 4.
- K093250: Proton Therapy Multileaf Collimator, Varian Medical Systems (2009) Summary page 4.

## Indications for use
The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Source page: https://510kreport.com/device/K152207
Methodology: https://510kreport.com/methodology