510(k) · Cleared
ClearedMucheck Monitor Unit Validation Program
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 1 generation backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- This deviceK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- Descendant · cites it directly · 80 of its ownK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- Descendant · 2 generations on · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- Descendant · 3 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- Descendant · 3 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| 0 (this device) | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| +1 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| +2 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| +3 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| +3 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| +1 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 9 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 8 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K914698 | Setup Computer with Software V-1261,62 and 63Summary 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… | 1992 |
What descends from it? (122)
See all 1223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
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.
https://510kreport.com/device/K980904 · printed Nov 6, 2026
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