510(k) · Cleared
ClearedBeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · IYE Accelerator, Linear, Medical
Cleared on May 31, 2024 as substantially equivalent to K103193 (Standard Imaging, Inc., 2010) after a 267-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- May 31, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854880 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK854880 Radiation Beam Data Acquistioin SystemsComputerized Medical Systems, Inc. · 1986
- 1 generation backK103193 Doseview 3DStandard Imaging, Inc. · 2010
- This deviceK232738 BeamDose software (S080053); BEAMSCAN software, option reference…Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854880 | Radiation Beam Data Acquistioin Systems | Computerized Medical Systems, Inc. | 1986 | — |
| −1 | K103193 | Doseview 3D | Standard Imaging, Inc. | 2010 | — |
| 0 (this device) | K232738 | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry… | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2024 | — |
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? (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 |
|---|---|---|---|
| * | K103193 | Doseview 3DSummary page 4…his summary: 2024-05-31 2 Predicate Device Information Proprietary name: DoseView 3D Common name: Water Phantom Scanning System 510(k) number: K103193 Regulation number: 21 CFR 892.5050 Regulation name: Medical charged-particle radiation therapy system Classification na… | 2010 |
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?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 25.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
BeamDose is a software for the following purposes in radiotherapy: – absolute dose measurements as field class dosemeter (according to IEC 60731) – monitor calibration – positioning of detectors in PTW water phantoms The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731. The software…
Read the full statement (155 words)
BeamDose is a software for the following purposes in radiotherapy:
– absolute dose measurements as field class dosemeter (according to IEC 60731)
– monitor calibration
– positioning of detectors in PTW water phantoms
The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.
The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results.
Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.
The measured absolute dose values must not be used directly in radiation therapy.
They have to be checked for plausibility by qualified personnel.
The software must be used only by qualified personnel, usually the medical physicist responsible
for the radiotherapy system or an authorized person.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232738: BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232738
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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