510(k) Report

510(k) · Cleared

Cleared

Mucheck Monitor Unit Validation Program

K980904510(k) TraditionalCleared Jun 8, 199890-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

Medical Dosimetry Services, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jun 8, 1998 as substantially equivalent to K914698 (K.S., Inc., 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 122 later devices descend from it.

Decided
Jun 8, 1998
Review
90 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K914698 (1992). 122 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2001: 2 descendants cleared2006: 7 descendants cleared2007: 3 descendants cleared2009: 9 descendants cleared2008: 4 descendants cleared2000: 1 descendant cleared2014: 5 descendants cleared2016: 8 descendants cleared2013: 3 descendants cleared2020: 6 descendants cleared2010: 5 descendants cleared2003: 3 descendants cleared2004: 4 descendants cleared2002: 2 descendants cleared2015: 5 descendants cleared2018: 6 descendants cleared2017: 5 descendants cleared2026: 6 descendants cleared2019: 4 descendants cleared2022: 6 descendants cleared2024: 3 descendants cleared2025: 4 descendants cleared2005: 1 descendant cleared2011: 5 descendants cleared2021: 4 descendants cleared2023: 5 descendants cleared2012: 5 descendants clearedK914698 · Setup Computer with Software V-1261,62 and 63 · K.S., Inc. · 19921990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 12 descendants4 generations forward: 19 descendants5 generations forward: 16 descendants6 generations forward: 11 descendants7 generations forward: 22 descendants8 generations forward: 9 descendants9 generations forward: 4 descendants10 generations forward: 7 descendants11 generations forward: 5 descendants12 generations forward: 4 descendants13 generations forward: 2 descendants14 generations forward: 3 descendants K914698 · Setup Computer with Software V-1261,62 and 63 · K.S., Inc. · 19920+5+10
  1. Root · 1 generation backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
  2. This deviceK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
  3. Descendant · cites it directly · 80 of its ownK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
  4. Descendant · 2 generations on · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  5. Descendant · 3 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
  6. Descendant · 3 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
  7. Descendant · cites it directly · 40 of its ownK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001

Showing 5 of 122 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12001: 22002: 22003: 32004: 42005: 12006: 72007: 32008: 42009: 92010: 52011: 52012: 52013: 32014: 52015: 52016: 82017: 52018: 62019: 42020: 62021: 42022: 62023: 52024: 32025: 42026: 6
1999high 9 (2009) · low 1 (1999)2026

Most influential descendants

Showing 5 of 122 · See all
  • K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999 · cites it directly80descendants
  • K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000 · 2 generations on79descendants
  • K013112Focal SimComputerized Medical Systems, Inc. · 2001 · 3 generations on47descendants
  • K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · 3 generations on44descendants
  • K012227Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001 · cites it directly40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K914698Setup Computer with Software V-1261,62 and 63K.S., Inc.1992—
0 (this device)K980904Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc.1998—
+1K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc.1999—
+2K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories2000—
+3K013112Focal SimComputerized Medical Systems, Inc.200110
+3K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories20031
+1K012227Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200120
200220
200330
200440
200510
200670
200730
200840
200990
201050
201150
201250
201330
201450
201550
201680
201750
201860
201940
202060
202140
202260
202350
202430
202540
202660
FIG. 1 — Lineage of K980904, 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
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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
*K914698Setup Computer with Software V-1261,62 and 63
Summary page 1
…tem(Accessory) 21 CFR 892.5050 (class o)y Performance Standards: none established under section 514 Substantial Equivalence: K & S Associates, PC Setup Program 510(k) K 914698 Description: The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatible…
K.S., Inc.1992—

Also cleared against K914698: 1 other device →

What descends from it? (122)

See all 122

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc.199980
K012227Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc.200140
K061152Mucheck V7.0Oncology Data Systems, Inc.200621

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.
  • Of its descendants, K990833 (Integrity Medical Software, Inc., 1999) has gone furthest, with 80 descendants of its own.
  • 1 other device also cites its predicate K914698.

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?

In a radiation therapy department a course of patient treatment is prescribed by a written directive from the radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the beam therapy. As part…

Read the full statement (475 words)

In a radiation therapy department a course of patient treatment is prescribed by a written directive from the radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the beam therapy. As part of the planning process, a monitor unit setting will be calculated which determines the machine duration of beam exposure. The primary radiation treatment planning software may or may not calculate the monitor unit setting. Regardless, the dosimetrist or physicist will either perform a manual calculation or perhaps use an in-house developed spreadsheet or program to calculate the monitor unit setting.

A manual calculation will involve the dosimetrist looking up beam data factors from a booklet of measured beam data provided by the physicist. These beam data factors are unique to each machine and must be measured by the physicist. The beam data booklet can contain 50 or more pages for a typical machine consisting of 2 photon beams and 5 electron beams. These factors are plugged into a standardized worksheet and a calculator is used to compute the monitor unit setting. This can be a tedious, time consuming process as well as error prone. The dosimetrist may have to search through multiple pages of data to find the correct factors to use. They will then have to be written down on the worksheet to be used for the final monitor unit calculation. Ideally they should be double checked for accuracy.

The muCheck Monitor Unit Validation Program (the device under review) makes this process much faster and more accurate. Initially, all of the beam data factors for each beam energy are entered into the system one time and stored in a database as part of the pre-installation process. After entry these factors are then plotted on a graph and printed along with tables of actual values entered to verify accuracy of data entry. To use the program, the dosimetrist simply enters the key data parameters as prompted by the program. As the parameters are entered into the system, beam factors are looked up and are automatically used by the program to calculate the correct monitor unit setting. All of the pertinent calculation data is displayed on the screen in worksheet form. This worksheet can be printed out and stored in the patients chart for permanent documentation. There are many user mput-edits incorporated into the system during the pre-installation process to insure the accuracy of the calculation. It must be stressed that this program does not provide the primary treatment calculation. It merely serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

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. “K980904: Mucheck Monitor Unit Validation Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980904

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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