510(k) · Cleared
ClearedPhoton Radiosurgery System (PRS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photoelectron Corporation · JAD System, Therapeutic, X-Ray
Cleared on Sep 23, 1999 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) and 2 other predicates after a 52-day review. Its family tree reaches back 2 generations to 1986. 20 later devices descend from it.
- Decided
- Sep 23, 1999
- Review
- 52 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864210 (1986). 6 ancestors in all, the oldest K852907 (1985). 20 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 1 generation backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- This deviceK992577 Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999
- Descendant · cites it directly · 9 of its ownK051055 Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · Recalled
- Descendant · cites it directly · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- Descendant · cites it directly · 8 of its ownK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- Descendant · 2 generations on · 5 of its ownK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K051055Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · cites it directly9descendants
- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · cites it directly8descendants
- K050843Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005 · cites it directly8descendants
- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · 2 generations on5descendants
- K072683Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −1 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| 0 (this device) | K992577 | Photon Radiosurgery System (PRS) | Photoelectron Corporation | 1999 | — |
| +1 | K051055 | Intrabeam System | Carl Zeiss Surgical GmbH | 2005 | 2 |
| +1 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| +1 | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
| +2 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| +2 | K072683 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953946 | Microselectron-HDR Version 2Summary page 1…EDICATE DEVICES The PRS and PRS Spherical Applicators are substantially equivalent to the following devices: Nucletron-Oldelft microSelectron-HDR brachytherapy device (K953946) Varian VariSource Remote Afterloader for High Dose Brachytherapy (K945383) Intraop Medical MOBETRON System (K981112) DEVICE DES… | 1996 |
| * | K945383 | High Dose Rate AfterloaderSummary page 1…uivalent to the following devices: Nucletron-Oldelft microSelectron-HDR brachytherapy device (K953946) Varian VariSource Remote Afterloader for High Dose Brachytherapy (K945383) Intraop Medical MOBETRON System (K981112) DEVICE DESCRIPTION The Photoelectron Corporation Photon Radiosurgery System (PRS) is… | 1995 |
| * | K981112 | MobetronSummary page 1…ron-Oldelft microSelectron-HDR brachytherapy device (K953946) Varian VariSource Remote Afterloader for High Dose Brachytherapy (K945383) Intraop Medical MOBETRON System (K981112) DEVICE DESCRIPTION The Photoelectron Corporation Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low energy X… | 1998 |
What descends from it? (20)
See all 204 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K051055 (Carl Zeiss Surgical GmbH, 2005) has gone furthest, with 9 descendants of its own.
- 27 other devices also cite its predicate K953946.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992577: Photon Radiosurgery System (PRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992577
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026