# K964947: Photon Radiosurgery System (PRS)

- Pathway: 510(k) (Traditional)
- Applicant: Photoelectron Corporation
- Decided: Jun 20, 1997 after 192 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
No predicates in its family tree.
12 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Nucletron-Oldelft microSelectron-HDR interstitial brachytherapy device: named in the summary without a submission number
- (no number) Elekta Radiosurgery Inc. Leksell Gamma Unit Model 23004: named in the summary without a submission number

## Most influential descendants
- K980526: Photon Radiosurgery System PRS400 (1998), 11 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K964947
Methodology: https://510kreport.com/methodology