510(k) · Cleared
ClearedVelos Constancy Check Device, Model 55-145
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 29, 1997 as substantially equivalent to K874893 (Keithley Instruments, Inc., 1988) after a 176-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jul 29, 1997
- Review
- 176 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874893 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK874893 Model 35300 Tracker (TM) Therapy Beam EvaluatorKeithley Instruments, Inc. · 1988
- This deviceK970384 Velos Constancy Check Device, Model 55-145Aktina Medical Physics Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874893 | Model 35300 Tracker (TM) Therapy Beam Evaluator | Keithley Instruments, Inc. | 1988 | — |
| 0 (this device) | K970384 | Velos Constancy Check Device, Model 55-145 | Aktina Medical Physics Corp. | 1997 | — |
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? (1)
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 |
|---|---|---|---|
| * | K874893 | Model 35300 Tracker (TM) Therapy Beam EvaluatorSummary page 2…na Medical Physics Corporation 360 North Route 9W Congers, N.Y. 10920 Name of Predicate Devices: (1) Keithly Instruments, Inc., Tracker Therapy Beam Evaluation system (K874893) Classification This device is classified as a class II device according to 21 CFR 892.5050 Performance Standards Performance… | 1988 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K874893.
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 AKTINA “Velos” Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893. More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of 2 medical physicist. Not intended as a substitute for machine…
Read the full statement (157 words)
The AKTINA “Velos” Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893.
More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of 2 medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology.
“Velos” is designed to operate by either:
a. being mounted on standard beamblock trays or,
b. placed on a table, when measurements are needed from various SID’s
and functions in an efficient and reliable way through reduction of setup time, remnote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.
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/K970384 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970384: Velos Constancy Check Device, Model 55-145.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970384
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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