510(k) · Cleared
ClearedAktina Medical Physics Corporation Tilt Board
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aktina Medical Physics Corp. · IYE Accelerator, Linear, Medical
Cleared on Jul 30, 1999 as substantially equivalent to K904005 (Huestis Machine Corp., 1990) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Jul 30, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904005 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK904005 Huestis Flexi-BoardHuestis Machine Corp. · 1990
- This deviceK991546 Aktina Medical Physics Corporation Tilt BoardAktina Medical Physics Corp. · 1999
- Descendant · cites it directly · 0 of its ownK032248 Precise Carbon Fiber Table Top, Model 11-999Aktina Medical Physics Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K032248Precise Carbon Fiber Table Top, Model 11-999Aktina Medical Physics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904005 | Huestis Flexi-Board | Huestis Machine Corp. | 1990 | — |
| 0 (this device) | K991546 | Aktina Medical Physics Corporation Tilt Board | Aktina Medical Physics Corp. | 1999 | — |
| +1 | K032248 | Precise Carbon Fiber Table Top, Model 11-999 | Aktina Medical Physics Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K904005 | Huestis Flexi-BoardSummary page 1…360 North Route 9 W Congers, New York, 10920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865 Name of Predicate Devices Huestis Medical Flexi-board (K904005) and Med-Tec Corporation MT-200 Breast Boards (K935412}. 1 Any statement made in conjunction with this submission regarding subs… | 1990 |
| * | K935412 | Med-Tec, Inc. Breast Board, MT-200Summary page 1…4-268-0101 FAX: 914-268-1700 Registration Number: 2436865 Name of Predicate Devices Huestis Medical Flexi-board (K904005) and Med-Tec Corporation MT-200 Breast Boards (K935412}. 1 Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates t… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032248 | Precise Carbon Fiber Table Top, Model 11-999 | 2003 | 0 |
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?
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?
Tilt Boards are also commonly known as Breast Boards and are intended for use in Radiation Therapy to facilitate patient positioning in irradiation of the breast.
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/K991546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991546: Aktina Medical Physics Corporation Tilt Board.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991546
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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