510(k) Report

510(k) · Cleared

Cleared

Dose Calc, Model VS. 1.02

K990833510(k) TraditionalCleared Jun 8, 199988-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2000: 1 descendant cleared2003: 3 descendants cleared2001: 1 descendant cleared2009: 7 descendants cleared2004: 4 descendants cleared2002: 2 descendants cleared2007: 2 descendants cleared2006: 6 descendants cleared2008: 3 descendants cleared2005: 1 descendant cleared2010: 4 descendants cleared2011: 5 descendants cleared2012: 5 descendants cleared2013: 2 descendants cleared2020: 4 descendants cleared2016: 3 descendants cleared2015: 4 descendants cleared2014: 3 descendants cleared2018: 4 descendants cleared2023: 3 descendants cleared2019: 2 descendants cleared2017: 2 descendants cleared2021: 3 descendants cleared2022: 2 descendants cleared2024: 1 descendant cleared2026: 3 descendants clearedReference device: K951581 · PINNACLE3 Apex · Adac Laboratories · 1996K914698 · Setup Computer with Software V-1261,62 and 63 · K.S., Inc. · 1992K980904 · Mucheck Monitor Unit Validation Program · Medical Dosimetry Services, Inc. · 19981990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 8 descendants5 generations forward: 8 descendants6 generations forward: 19 descendants7 generations forward: 8 descendants8 generations forward: 4 descendants9 generations forward: 7 descendants10 generations forward: 5 descendants11 generations forward: 4 descendants12 generations forward: 2 descendants13 generations forward: 3 descendants K980904 · Mucheck Monitor Unit Validation Program · Medical Dosimetry Services, Inc. · 1998K914698 · Setup Computer with Software V-1261,62 and 63 · K.S., Inc. · 19920+5+10
  1. Root · 2 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
  2. 1 generation backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
  3. This deviceK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
  4. Descendant · cites it directly · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  5. Descendant · 2 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
  6. Descendant · 2 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
  7. Descendant · 3 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
  8. 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

2000: 12001: 12002: 22003: 32004: 42005: 12006: 62007: 22008: 32009: 72010: 42011: 52012: 52013: 22014: 32015: 42016: 32017: 22018: 42019: 22020: 42021: 32022: 22023: 32024: 12026: 3
2000high 7 (2009) · low 0 (2025)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−2K914698Setup Computer with Software V-1261,62 and 63K.S., Inc.1992—
−1K980904Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc.1998—
0 (this device)K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc.1999—
+1K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories2000—
+2K013112Focal SimComputerized Medical Systems, Inc.200110
+2K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories20031
+3K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories20047
+3K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200220
200330
200440
200510
200660
200720
200830
200970
201040
201150
201250
201320
201430
201540
201630
201720
201840
201920
202040
202130
202220
202330
202410
202630
FIG. 1 — Lineage of K990833, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K980904Mucheck Monitor Unit Validation Program
Summary 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…
Medical Dosimetry Services, Inc.1998—
†K951581PINNACLE3 ApexAdac Laboratories1996—

Also cleared against K980904: 2 other devices →

What descends from it? (80)

See all 80

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories200079

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 devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

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.

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

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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