# K192196: Medical Radiation Dosimetry System microSTARii

- Pathway: 510(k) (Traditional)
- Applicant: Landauer
- Decided: Dec 27, 2019 after 136 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092285 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092285: Portable Dosimeter Dose Verification System, Model TD-RD-90, Best Medical Canada, Ltd. (2009) Summary page 4.

## Recalls of this device
- Nov 15, 2023 · Class II · Z-0616-2024: 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 
- Jul 12, 2023 · Class II · Z-2545-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2565-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2551-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2552-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2569-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2538-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2574-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2555-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2567-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2548-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2546-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2547-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2549-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2544-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2568-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2561-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2553-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2564-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2539-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2554-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2563-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2566-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2557-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2550-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2560-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2573-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2541-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2556-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2570-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2559-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2558-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2562-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2571-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2575-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2543-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2540-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2542-2023: 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-confo
- Jul 12, 2023 · Class II · Z-2572-2023: 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-confo

## Indications for use
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.

Source page: https://510kreport.com/device/K192196
Methodology: https://510kreport.com/methodology