The following data is part of a premarket notification filed by Landauer with the FDA for Medical Radiation Dosimetry System Microstarii.
| Device ID | K192196 |
| 510k Number | K192196 |
| Device Name: | Medical Radiation Dosimetry System MicroSTARii |
| Classification | Accelerator, Linear, Medical |
| Applicant | Landauer 2 Science Rd. Glenwood, IL 60425 |
| Contact | Matt Ennis |
| Correspondent | Matt Ennis Landauer 2 Science Rd. Glenwood, IL 60425 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-13 |
| Decision Date | 2019-12-27 |
| Summary: | summary |