510(k) · Cleared
ClearedDose Calc, Model VS. 1.02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrity Medical Software, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jun 8, 1999 as substantially equivalent to K980904 (Medical Dosimetry Services, Inc., 1998) after an 88-day review. Its family tree reaches back 2 generations to 1992. 80 later devices descend from it.
- Decided
- Jun 8, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914698 (1992). 80 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 1 generation backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- This deviceK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- Descendant · cites it directly · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- Descendant · 2 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- Descendant · 3 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- Descendant · 3 generations on · 32 of its ownK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000 · cites it directly79descendants
- K013112Focal SimComputerized Medical Systems, Inc. · 2001 · 2 generations on47descendants
- K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · 2 generations on44descendants
- K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · 3 generations on39descendants
- K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −1 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| 0 (this device) | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| +1 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| +2 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| +2 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| +3 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| +3 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K980904 | Mucheck Monitor Unit Validation ProgramSummary page 1…ssory); 21 CFR 892.5050 (class II Performance Standards: none established under section 514 Substantial Equivalence: = muCheck — Monitor Unit Validation Program 510(k) K 980904 Description: DoseCalc is a software program that is designed to operate on a PC in a Windows environment on either a stand alon… | 1998 |
| † | K951581 | PINNACLE3 Apex | 1996 |
What descends from it? (80)
See all 801 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | 2000 | 79 |
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 7 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K993923 (Adac Laboratories, 2000) has gone furthest, with 79 descendants of its own.
- 2 other devices also cite its predicate K980904.
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?
DoseCalc is a program utilized in a radiation therapy department for the determination of monitor units. The Monitor Unit is a quantity used by a treatment machine for determining the length of time that it should remain on in order to deliver a prescribed amount of radiation to a point. Most of the time, a radiation treatment planning system is used to define the location and dose distribution of the radiation. Radiation therapy planning systems…
Read the full statement (521 words)
DoseCalc is a program utilized in a radiation therapy department for the determination of monitor units. The Monitor Unit is a quantity used by a treatment machine for determining the length of time that it should remain on in order to deliver a prescribed amount of radiation to a point. Most of the time, a radiation treatment planning system is used to define the location and dose distribution of the radiation. Radiation therapy planning systems typically calculate the monitor units needed to deliver the desired amount of radiation to a point of reference and thus produce the desired dose distribution within the patient. On occasion, a hand calculation will be performed in order to determine the number of monitor units needed to deliver the prescribed amount of radiation. DoseCalc is a program which allows the user to input data by hand through the use of the mouse or keyboard or electronically from the primary radiation therapy planning system. From this data, it will then determine the number of monitor units needed to be given to a patient. The process of calculating the monitor units involves DoseCalc automatically looking up the data parameters from previously inputted data and then calculating the monitor units from these values. This process greatly increases the speed at which a calculation can be performed and also eliminates many errors that occur from manually looking up the data. DoseCalc’s monitor unit calculation can then be used to validate the monitor units previously determined by hand or by the primary radiation therapy planning system. It is not the intention of DoseCalc to replace the calculation performed by the primary radiation therapy planning computer but to validate its calculation as a means of quality assurance. The practice of performing a secondary check is recommended by the American Association of Physicists in Medicine (AAPM) Task Group 40 as part of a good quality assurance program. This practice is an important aspect in providing quality patient care. DoseCalc is not only being submitted to perform this secondary function but to also be used as the primary means of calculating monitor units in situations where the physician does not order the use of a radiation therapy treatment plan. For this situation, it is important to accurately determine the monitor units needed for a patient’s treatment. DoseCalc provides this operation. It has many built in checks that will check for many common errors that occur when calculating monitor units as well as checking that the inputted parameters are within predefined limits for the treatment machine. The use of DoseCalc in this manner provides a means for accurately determining the monitor units. A physicist can then visually examine the inputted data for accuracy and verify the computed parameters to be sure that they are correct.
DoseCalc also allows for the transfer of the treatment planning data from the primary radiation therapy planning computer to DoseCalc and then to the facility’s Verify and Record system. This will reduce the number of errors that occur as a result of manually inputting this data. This feature merely transfers information from one system to another without performing any calculations.
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/K990833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990833: Dose Calc, Model VS. 1.02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990833
Report an extraction error
Are you the manufacturer?
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