510(k) · Cleared
Recalled · Class II · 2023Medical Radiation Dosimetry System microSTARii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Landauer · IYE Accelerator, Linear, Medical
Cleared on Dec 27, 2019 as substantially equivalent to K092285 (Best Medical Canada, Ltd., 2009) after a 136-day review. Its family tree reaches back 1 generation to 2009. It has been recalled 39 times.
- Decided
- Dec 27, 2019
- Review
- 136 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 39
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092285 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK092285 Portable Dosimeter Dose Verification System, Model TD-RD-90Best Medical Canada, Ltd. · 2009
- This deviceK192196 Medical Radiation Dosimetry System microSTARiiLandauer · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092285 | Portable Dosimeter Dose Verification System, Model TD-RD-90 | Best Medical Canada, Ltd. | 2009 | — |
| 0 (this device) | K192196 | Medical Radiation Dosimetry System microSTARii | Landauer | 2019 | — |
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 |
|---|---|---|---|
| * | K092285 | Portable Dosimeter Dose Verification System, Model TD-RD-90Summary page 4…icle radiation therapy system Device Classification: Class II Product Code: IYE Predicate Device(s): Portable Dosimeter, K092285 Best Medical Canada, Ltd. Class II, Product Code IY… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2023 | Class II | Z-0616-2024 | Other | MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris… |
| Jul 12, 2023 | Class II | Z-2545-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2565-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2551-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2552-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2569-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2538-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2574-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2555-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2567-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2548-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2546-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2547-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2549-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2544-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2568-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2561-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2553-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2564-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2539-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2554-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2563-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2566-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2557-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2550-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2560-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2573-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2541-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2556-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2570-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2559-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2558-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2562-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2571-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2575-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2543-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2540-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2542-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
| Jul 12, 2023 | Class II | Z-2572-2023 | Under Investigation by firm | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated… |
The 5 latest of 39 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K092285.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2007high 28 (2012) · low 9 (2024)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
2007high 239 (2024) · low 44 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
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
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
| 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 LANDAUER® microSTAR®ii Medical Dosimetry System provides an accurate, reliable and easy-to-use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure patient dose, the system is used to provide a secondary verification of radiation dose as a means of Quality Control for the primary dose calculation method. The output of the microSTAR®ii system is not used to adjust the dose to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192196 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192196: Medical Radiation Dosimetry System microSTARii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192196
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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