510(k) · Cleared
ClearedDoseview 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Imaging, Inc. · IYE Accelerator, Linear, Medical
Cleared on Dec 27, 2010 as substantially equivalent to K854880 (Computerized Medical Systems, Inc., 1986) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.
- Decided
- Dec 27, 2010
- Review
- 59 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K854880 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK854880 Radiation Beam Data Acquistioin SystemsComputerized Medical Systems, Inc. · 1986
- This deviceK103193 Doseview 3DStandard Imaging, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK232738 BeamDose software (S080053); BEAMSCAN software, option reference…Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2024
Most influential descendants
Showing 1 of 1 · See all- K232738BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854880 | Radiation Beam Data Acquistioin Systems | Computerized Medical Systems, Inc. | 1986 | — |
| 0 (this device) | K103193 | Doseview 3D | Standard Imaging, Inc. | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K854880 | Radiation Beam Data Acquistioin SystemsSummary page 1…ry: Computerized Medical Systems, Inc., DynaScan Radiation Beam Data Acquisition System - 5 10(k) K854880 Secondary: PTW - New York Corp., MP3 Automatic Water Phantom - 5 10(k) Number K9… | 1986 |
| * | K954165 | PTW-MP3 & PTW-MP3S Automatic Water PhantomSummary page 1…5 10(k) K854880 Secondary: PTW - New York Corp., MP3 Automatic Water Phantom - 5 10(k) Number K954165 Contact Person: Raymond Riddle, PE, RAC, Chief Regulatory Officer The 5 10(k)… | 1995 |
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 |
|---|---|---|---|
| K232738 | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) | 2024 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K232738 (Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The DoseView 3D system is a 3 axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear accelerated-based radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. *This data is then often used in support of a radiation treatment planning system. It is comprised of a water tank, electrometer, radiation detector(s), motion…
Read the full statement (156 words)
The DoseView 3D system is a 3 axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear accelerated-based radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. *This data is then often used in support of a radiation treatment planning system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist. The general uses of the DoseView 3D include the following:
* Acceptance testing and/or commissioning of a radiation therapy or radiotherapy system.
* Quality assurance measurements to identify and minimize the sources of uncertainty and. error in the radiation therapy system, radiotherapy system or radiation treatment planning system.
* Collection of dose depth data for radiation treatment planning system use.
* Completion of clinical dosimetry protocols and calibrations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103193: Doseview 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103193
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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