# K980526: Photon Radiosurgery System PRS400

- Pathway: 510(k) (Traditional)
- Applicant: Pec Photoelectron Corp.
- Decided: Jul 27, 1998 after 167 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964947 (1997). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964947: Photon Radiosurgery System (PRS), Photoelectron Corporation (1997) Summary page 1.

## Most influential descendants
- K051055: Intrabeam System (2005), 9 descendants of its own
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own
- K133655: Radiance V2 (2014), 5 descendants of its own
- K153368: Radiance V3 (2016), 4 descendants of its own
- K171885: Radiance V4 (2017), 3 descendants of its own

## Indications for use
The Photon Radiosurgery System is intended to be used for the irradiation on intracranial tumors.

Source page: https://510kreport.com/device/K980526
Methodology: https://510kreport.com/methodology