510(k) · Cleared
ClearedIQM Integral Quality Monitor (also IQM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irt Systems · IYE Accelerator, Linear, Medical
Cleared on Oct 20, 2016 as substantially equivalent to K062817 (Ptw-New York Corp., 2006) after a 29-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Oct 20, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874893 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK874893 Model 35300 Tracker (TM) Therapy Beam EvaluatorKeithley Instruments, Inc. · 1988
- 2 generations backK972211 Multidos, QC6PLUSPtw-New York Corp. · 1997
- 1 generation backK062817 PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006
- This deviceK162629 IQM Integral Quality Monitor (also IQM)Irt Systems · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874893 | Model 35300 Tracker (TM) Therapy Beam Evaluator | Keithley Instruments, Inc. | 1988 | — |
| −2 | K972211 | Multidos, QC6PLUS | Ptw-New York Corp. | 1997 | — |
| −1 | K062817 | PTW David Imrt QC Verification System | Ptw-New York Corp. | 2006 | — |
| 0 (this device) | K162629 | IQM Integral Quality Monitor (also IQM) | Irt Systems | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K062817 | PTW David Imrt QC Verification SystemSummary page 4…CFR 892.5050) (IQM is an accessory device) Regulatory Class: II Product Code: IYE 3 PREDICATE DEVICE PTW DAVID, 510(k)# K062817 This predicate device has not been subject to a design-related recall1. No reference devices were used in thi… | 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 28 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K062817.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The IQM Integral Quality Monitor is a large-area ionization chamber intended to be used for quality assurance
verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from
medical linear accelerators used for intensity modulated radiation therapy.
The data acquired by IQM is used to compare and verify a treatment dose (delivered dose) to the expected dose and to
compile treatment delivery radiation beam data over time as part of a quality assurance program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162629: IQM Integral Quality Monitor (also IQM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162629
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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