510(k) · Cleared
ClearedStandard Imaging E.Imrt Calculator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Imaging, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 11, 2004 as substantially equivalent to K951581 (Adac Laboratories, 1996) and 2 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- May 11, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K914698 (1992). 14 ancestors in all, the oldest K894706 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 4 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 3 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 2 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 1 generation backK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- This deviceK040688 Standard Imaging E.Imrt CalculatorStandard Imaging, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −4 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −3 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −2 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −1 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| 0 (this device) | K040688 | Standard Imaging E.Imrt Calculator | Standard Imaging, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.7 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K951581 | PINNACLE3 ApexSummary page 1…equivalent to the electron portion of the ADAC Laboratories (Philips) Pinnacle 3 Radiation Therapy Planning Software covered by 5 10(k) Numbers K95 158 1, K993923, K032724. The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use… | 1996 |
| * | K993923 | Adac PINNACLE3TM Radiation Therapy Planning SystemSummary page 1…to the electron portion of the ADAC Laboratories (Philips) Pinnacle 3 Radiation Therapy Planning Software covered by 5 10(k) Numbers K95 158 1, K993923, K032724. The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use… | 2000 |
| * | K032724 | PINNACLE3 Radiation Therapy Planning SystemSummary page 1…ectron portion of the ADAC Laboratories (Philips) Pinnacle 3 Radiation Therapy Planning Software covered by 5 10(k) Numbers K95 158 1, K993923, K032724. The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an app… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 1 of the 14 ancestors has a recall of any class.
- 4 other devices also cite its predicate K951581.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient. Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user…
Read the full statement (250 words)
The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient.
Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4, 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used.
The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam treatment energies, in both numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts.
Specific electron beam parameters are selected from the solution options provided by the e.IMRT Calculator for non-direct (manual) input into tlhe user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementatio with a linear accelerator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040688 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040688: Standard Imaging E.Imrt Calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040688
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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