510(k) · Cleared
ClearedStandard Imaging Imsure Brachy QA Software, Model 91331
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Imaging, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 19, 2008 as substantially equivalent to K031975 (Prodigm, Inc., 2003) and 1 other predicate after a 58-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Nov 19, 2008
- Review
- 58 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914698 (1992). 8 ancestors in all, the oldest K911612 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 3 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 2 generations backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 1 generation backK061152 Mucheck V7.0Oncology Data Systems, Inc. · 2006
- This deviceK082773 Standard Imaging Imsure Brachy QA Software, Model 91331Standard Imaging, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −3 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −2 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −1 | K061152 | Mucheck V7.0 | Oncology Data Systems, Inc. | 2006 | — |
| 0 (this device) | K082773 | Standard Imaging Imsure Brachy QA Software, Model 91331 | Standard Imaging, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 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? (2)
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 |
|---|---|---|---|
| * | K031975 | ImsureSummary page 1…gy Predicate Devices: Primary: Standard Imaging (Prodigm), IMSure QA Software 5 10(k) Number K031975 Secondary: Oncology Data Systems, MU Check v7.0 (Brachy Check)… | 2003 |
| * | K061152 | Mucheck V7.0Summary page 1…Secondary: Oncology Data Systems, MU Check v7.0 (Brachy Check) 5 10(k) Number K061152 Contact Person: Raymond Riddle, PE, RAC Chief Regulatory Officer The 5… | 2006 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K031975.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products. This product is intended for use by trained medical physicists, physicians, or…
Read the full statement (147 words)
IMSure Brachy QA Software is a stand alone software application product intended for
use as a quality assurance tool to verify brachytherapy treatment plans developed on a
radiation therapy treatment planning system with the appropriate transfer format. It may
also be used as a segregated standalone application in the IMSure QA Software suite of
software products.
This product is intended for use by trained medical physicists, physicians, or dosimetrists.
The calculation results must be evaluated by qualified personnel before a patient
treatment. It is the responsibility of the medical physicist, physician or dosimetrist to
determine whether the dosimetric accuracy is adequate for a particular patient.
Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted
to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082773 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082773: Standard Imaging Imsure Brachy QA Software, Model 91331.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082773
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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