# K992577: Photon Radiosurgery System (PRS)

- Pathway: 510(k) (Traditional)
- Applicant: Photoelectron Corporation
- Decided: Sep 23, 1999 after 52 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: 2 generations back to K864210 (1986). 6 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.
- K945383: High Dose Rate Afterloader, Varian Assoc., Inc. (1995) Summary page 1.
- K981112: Mobetron, Intraop Medical, Inc. (1998) 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
- K050843: Axxent Electronic Brachytherapy System (2005), 8 descendants of its own
- K133655: Radiance V2 (2014), 5 descendants of its own
- K072683: Axxent Electronic Brachytherapy System (2008), 5 descendants of its own

## Indications for use
The Photon Radiosurgery System (PRS) is indicated for radiation therapy treatments. The PRS Spherical Applicators are indicated for use with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments.

Source page: https://510kreport.com/device/K992577
Methodology: https://510kreport.com/methodology