510(k) · Cleared
ClearedAdvanced Treatment Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Radiation Therapy Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jan 23, 1998 as substantially equivalent to K915691 (Computerized Medical Systems, Inc., 1995) and 1 other predicate after a 178-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 23, 1998
- Review
- 178 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915691 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915691 Focus RTPComputerized Medical Systems, Inc. · 1995
- This deviceK972816 Advanced Treatment Planning SystemAdvanced Radiation Therapy Systems, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915691 | Focus RTP | Computerized Medical Systems, Inc. | 1995 | — |
| 0 (this device) | K972816 | Advanced Treatment Planning System | Advanced Radiation Therapy Systems, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K915691 | Focus RTPSummary page 1…ing of Prussia, Pa 19406 Corresponding Official: Mr. Alexander C. Cheung Title: Chief Executive Officer Telephone: 610-265-6519 Fax: 610-354-9226 Predicate: Focus RTP: K915691 and Xknifc-3: K953482 Device Description: The Advanced Treatment Planning System (ATPS) from Advanced Radiation Therapy Systems,… | 1995 |
| * | K953482 | Xknife-3Summary page 1…06 Corresponding Official: Mr. Alexander C. Cheung Title: Chief Executive Officer Telephone: 610-265-6519 Fax: 610-354-9226 Predicate: Focus RTP: K915691 and Xknifc-3: K953482 Device Description: The Advanced Treatment Planning System (ATPS) from Advanced Radiation Therapy Systems, Inc. (ARTS) is a soft… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K915691.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Advanced Radiation Therapy Systems, Inc., “Advanced Treatment Planning System” is used
to plan patient treatments for radiation therapy with external photons and electrons.
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/K972816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972816: Advanced Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972816
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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